CALDERWOOD & HARKNESS LLP Attorneys at Law 1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: (202) 555-7100
MEMORANDUM
PRIVILEGED AND CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION
Date: May 19, 2025
To: Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd. Marcus Hale, Vice President of U.S. Operations, Solstice Biomedical Inc.
From: Miriam Calloway, Partner, Calderwood & Harkness LLP Amy Whitfield, Associate, Calderwood & Harkness LLP
Re: Permissible Marketing and Promotional Claims for the Solstice Lumina™ CGM System — Pre- and Post-510(k) Clearance
Engagement Reference No.: 1037-00002
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I. Executive Summary
This memorandum provides legal guidance to Solstice Biomedical Devices Ltd. ("Solstice" or "SBD") and its wholly owned U.S. subsidiary, Solstice Biomedical Inc. ("SBI"), a Delaware corporation (Delaware Secretary of State File No. 7834291), regarding the scope of permissible marketing and promotional activities in the United States for the Solstice Lumina™ Continuous Glucose Monitoring System (the "Lumina CGM System" or the "System"). The Lumina CGM System comprises two principal components: the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter. Together, these components are intended to provide continuous glucose monitoring in adults with diabetes mellitus.
As of the date of this memorandum, the Lumina CGM System does not have clearance from the United States Food and Drug Administration ("FDA"). SBI's current regulatory timeline targets submission of a traditional 510(k) premarket notification to FDA's Center for Devices and Radiological Health ("CDRH") by April 30, 2026, with an anticipated clearance decision in the third quarter of 2026 (Q3 2026) and a planned U.S. commercial launch in the fourth quarter of 2026 (Q4 2026). A Pre-Submission meeting with CDRH's Office of Health Technology 2 — Division of Chemistry and Toxicology Devices is targeted for August 14, 2025, in coordination with Pinnacle Regulatory Consulting Group LLC.
It is important to note that the Lumina CGM System has received CE marking in the European Union under the Medical Device Regulation (EU) 2017/745 ("MDR"), pursuant to Certificate No. MCA-2024-07319, issued on September 12, 2024, by Meridian Conformity Assessment GmbH, Notified Body 0483. The System has been commercially available in the EU since September 2024. However, EU marketing authorization has no legal bearing whatsoever on the permissibility of U.S. promotional activities. The regulatory systems of the European Union and the United States operate independently, and CE marking does not substitute for, or authorize activities in lieu of, FDA clearance or approval.
Key Takeaway: Solstice and SBI must refrain from any promotional claims or marketing activities that could be construed as marketing, promoting, or commercially distributing an uncleared medical device in the United States prior to obtaining 510(k) clearance. Following clearance, all promotional claims must be truthful, non-misleading, adequately substantiated, and consistent with the cleared indications for use as stated in the device's FDA-cleared labeling.
This memorandum addresses the following principal topics:
1. Pre-clearance promotional restrictions — the legal boundaries governing what Solstice may and may not communicate regarding the Lumina CGM System prior to FDA clearance, including the management of EU marketing materials accessible from the United States;
2. The statutory and regulatory framework governing promotional claims — including the Federal Food, Drug, and Cosmetic Act ("FD&C Act"), FDA regulations and guidance documents, and the overlapping jurisdiction of the Federal Trade Commission ("FTC");
3. Post-clearance promotional claim parameters — the standards of truthfulness, non-misleadingness, adequate substantiation, and fair balance that apply to promotional claims following 510(k) clearance;
4. Comparative advertising limitations — with particular attention to the risks associated with promotional comparisons to products manufactured by NovaSense Medical Technologies Inc. ("NovaSense"), including the GlucoTrack NX-500 and GlucoTrack NX-700, which serve as predicate devices in SBI's 510(k) submission;
5. Off-label promotion risks — the prohibition on promoting the Lumina CGM System for uses, indications, or patient populations not included in the cleared labeling, and the narrow carve-outs for permissible scientific exchange; and
6. Social media and digital marketing considerations — the application of FDA promotional requirements to the evolving landscape of social media marketing, digital advertising, influencer engagements, and online content.
This memorandum is intended to serve as a comprehensive reference for Solstice's regulatory affairs, marketing, commercial, and communications teams. We strongly recommend that all external-facing promotional materials, website content, social media campaigns, investor communications, and press releases be submitted to Calderwood & Harkness for legal review prior to dissemination, as described in the specific recommendations set forth in Section VIII below.
II. Statutory and Regulatory Framework
The regulatory framework governing promotional claims for medical devices in the United States is principally derived from the FD&C Act and its implementing regulations, supplemented by FDA guidance documents and the overlapping enforcement authority of the FTC. This Section provides a detailed overview of the statutory and regulatory provisions most relevant to Solstice's promotional activities.
A. Section 502 of the Federal Food, Drug, and Cosmetic Act — Misbranding
Section 502 of the FD&C Act, codified at 21 U.S.C. § 352, establishes the central standard for device labeling and promotional claims. Under Section 502(a), a device is deemed "misbranded" if its labeling is "false or misleading in any particular." This standard is intentionally broad and encompasses not only affirmatively false statements but also statements that are technically accurate yet misleading by virtue of what they omit, how they are presented, or the context in which they appear.
The concept of "labeling" under the FD&C Act is considerably broader than the physical label affixed to a device. Section 201(m) of the FD&C Act, codified at 21 U.S.C. § 321(m), defines "labeling" to include "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." The Supreme Court's decision in Kordel v. United States, 335 U.S. 345 (1948), established that materials need not physically accompany a device in the literal sense; rather, the "accompanying" requirement is satisfied where there is a textual relationship between the device and the written material, such that the material supplements or explains the device. Under this expansive interpretation, FDA has consistently taken the position that the following categories of materials constitute "labeling" subject to the misbranding prohibitions of Section 502:
• Promotional brochures, pamphlets, and sell sheets distributed to healthcare professionals or patients;
• Product website content, including product descriptions, feature pages, and clinical data summaries;
• Trade show displays, booth materials, and presentation decks;
• Sales representative communications, including detail aids, leave-behind materials, and oral promotional statements;
• Press releases that contain promotional product claims;
• Video and multimedia content disseminated online or at medical conferences; and
• Social media posts, paid digital advertisements, and sponsored content.
It is critical that Solstice understand that FDA does not confine its regulatory oversight to the four corners of the physical product label. Any promotional communication that relates to the Lumina CGM System and is directed at U.S. audiences is potentially subject to the misbranding provisions of Section 502. A promotional claim that is false or misleading — whether made on the device's packaging, in a sales representative's verbal pitch, or in an Northpoint Services Inc. post — exposes Solstice to enforcement action.
Section 502(f) further provides that a device is misbranded unless its labeling contains adequate directions for use and adequate warnings against unsafe use. While this provision is most directly relevant to the device's physical labeling, it also informs the requirement for "fair balance" in promotional materials, as discussed in Section IV.C below.
B. Section 501 and Adulteration — Pre-Market Clearance Requirements
Distinct from the misbranding framework, Section 501(f) of the FD&C Act, codified at 21 U.S.C. § 351(f), addresses the adulteration of devices that lack required pre-market authorization. A Class II medical device for which a 510(k) premarket notification is required is deemed "adulterated" under Section 501(f)(1)(B) if it is introduced or delivered for introduction into interstate commerce without an effective 510(k) notification. In other words, the Lumina CGM System is, as a matter of law, an adulterated device in the United States until such time as FDA issues a clearance order for SBI's 510(k) submission.
The commercial distribution or marketing of an adulterated device constitutes a "prohibited act" under Section 301 of the FD&C Act, codified at 21 U.S.C. § 331. Specifically, Section 301(a) prohibits the introduction or delivery for introduction into interstate commerce of any device that is adulterated or misbranded, and Section 301(d) prohibits the introduction or delivery for introduction into interstate commerce of any article in violation of Section 501. Violations of Section 301 may result in civil penalties, criminal prosecution, seizure of devices, and injunctive relief.
Crucially, "marketing" for purposes of Section 301 is not limited to the physical shipment and sale of devices. FDA has taken the position that promoting an uncleared device for commercial distribution — even in the absence of actual commercial transactions — may constitute evidence of intent to introduce the device into interstate commerce and may trigger enforcement action. This principle has significant implications for Solstice's pre-clearance communications, as discussed in Section III below.
It is important to distinguish between promotional activity — which is prohibited prior to clearance — and legitimate pre-clearance scientific exchange, which is generally permissible under certain conditions. This distinction is addressed in detail in Section III.B below.
C. FD&C Act Section 510(k) and 21 C.F.R. Part 807 — Premarket Notification Requirements
The Lumina CGM System is classified as a Class II medical device for purposes of the 510(k) premarket notification process. SBI intends to submit a traditional 510(k) premarket notification covering both the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter as a single integrated system. The applicable product code is QKQ (Glucose Monitor, Continuous, Non-Invasive), corresponding to the device classification at 21 C.F.R. § 862.1355, which governs continuous glucose monitors and establishes the applicable special controls for such devices.
The 510(k) pathway requires SBI to demonstrate that the Lumina CGM System is "substantially equivalent" to one or more legally marketed predicate devices. As discussed in Section V.B below, SBI has identified the NovaSense GlucoTrack NX-500 (cleared under 510(k) No. K211034 on June 18, 2022) as the primary predicate device, with the NovaSense GlucoTrack NX-700 (cleared under 510(k) No. K230489 on March 7, 2024) serving as a secondary predicate and reference device.
Until 510(k) clearance is obtained, the Lumina CGM System may not be commercially distributed or promoted in the United States. This prohibition is absolute and is not subject to exceptions based on foreign marketing authorization, anticipated clearance timelines, or the perceived readiness of the product for the U.S. market.
Upon clearance, the scope of permissible promotional claims will be bounded by the indications for use as stated on FDA Form 3881 and reflected in the cleared labeling. Based on current regulatory planning and consultation with Pinnacle Regulatory Consulting Group LLC, the draft indications for use are as follows:
The Solstice Lumina™ CGM System is a prescription continuous glucose monitoring system indicated for the management of diabetes in persons aged 18 years and older with Type 1 or Type 2 diabetes mellitus. The system is intended to continuously measure interstitial glucose levels in the subcutaneous tissue. The system provides real-time glucose readings, trend information, and configurable alerts/alarms for the detection and prediction of episodes of hyperglycemia and hypoglycemia. The measurement range is 40–400 mg/dL. The sensor is intended for a maximum wear duration of 14 days (336 hours).
These indications define the outer boundary of permissible promotional claims post-clearance. Claims that expand the intended use beyond what is stated in the cleared labeling — for example, promoting the device for pediatric use, gestational diabetes, non-diabetic wellness monitoring, or sensor wear beyond 14 days — would constitute off-label promotion and are prohibited, as discussed in Section VI.
D. FDA Guidance Documents
FDA has issued a number of guidance documents that, while not legally binding, represent the Agency's current thinking on the interpretation and application of the FD&C Act's promotional requirements. These guidance documents are particularly relevant to Solstice's promotional planning and should be treated as authoritative statements of FDA expectations. Key guidance documents include:
"Guidance for Industry: Consumer-Directed Broadcast Advertisements" — This guidance, although originally developed in the prescription drug context, establishes principles relevant to broadcast advertising of medical devices, including the requirement that broadcast advertisements include adequate risk information and direct consumers to more complete labeling.
"Promoting Medical Products in a Changing Information Environment" — This guidance, developed through a series of public workshops, addresses the challenges of promoting medical products in digital and social media environments. It provides a framework for evaluating the adequacy of promotional communications on platforms with character limits, multimedia content, and user-generated interactions.
"Responding to Unsolicited Requests for Off-Label Information About Prescription Human Drug and Biological Products and Medical Devices" (Draft Guidance) — This draft guidance articulates FDA's position on the circumstances under which manufacturers may respond to unsolicited requests from healthcare professionals for information about uses of a device beyond its cleared indications. As discussed in Section VI.C, this guidance delineates the narrow boundary between permissible scientific exchange and impermissible off-label promotion.
"Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices/Biologics" — This guidance permits (but does not require) manufacturers to correct misinformation about their products posted independently by third parties on internet and social media platforms. If Solstice chooses to correct such misinformation, it must follow specific procedures outlined in the guidance, including identifying itself, providing correct information, and referring to the product's cleared labeling.
CDRH Guidance on Device Labeling Requirements — Various CDRH-issued guidance documents address specific labeling requirements for medical devices, including requirements for adequate directions for use, warnings and precautions, and the format and content of labeling for in vitro diagnostic and monitoring devices.
"Integrated Continuous Glucose Monitoring Systems" (September 2023) — This guidance is particularly relevant to Solstice's Lumina CGM System, as it addresses the regulatory pathway and special controls applicable to integrated CGM (iCGM) systems, including interoperability requirements and the criteria for iCGM classification.
"Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (September 2023) — To the extent that Solstice intends to make promotional claims regarding the cybersecurity features of the Lumina CGM System (e.g., encrypted BLE 5.2 connectivity, data security protocols), this guidance should be consulted to ensure that such claims are consistent with FDA's expectations for cybersecurity design and documentation.
Solstice's marketing and regulatory teams should maintain familiarity with these guidance documents and consult them when developing promotional content. Calderwood & Harkness is available to provide detailed analysis of any specific guidance document as it applies to particular promotional claims or marketing strategies.
E. FTC Jurisdiction and Overlap
In addition to FDA's jurisdiction over device labeling, the Federal Trade Commission ("FTC") exercises overlapping jurisdiction over advertising claims for medical devices. While FDA's authority under the FD&C Act extends principally to "labeling" (as broadly defined), the FTC's authority under Section 5 of the FTC Act, codified at 15 U.S.C. § 45, extends to "advertising" and other commercial practices. Section 5 prohibits "unfair or deceptive acts or practices in or affecting commerce," which includes false or misleading advertising of medical devices.
The practical effect of this dual jurisdiction is that Solstice's promotional claims for the Lumina CGM System are subject to scrutiny by both FDA and the FTC. The two agencies have historically coordinated their enforcement efforts through a series of memoranda of understanding and working agreements. In general, FDA exercises primary jurisdiction over the labeling of prescription medical devices, while the FTC exercises primary jurisdiction over advertising directed at consumers. However, the boundaries are not always clearly delineated, and both agencies may take enforcement action where they identify false or misleading claims.
Under the FTC's substantiation doctrine, an advertiser must have a "reasonable basis" for its advertising claims before disseminating those claims. For health-related claims — which include claims about the performance, accuracy, or safety of a CGM system — the FTC has generally required that claims be substantiated by "competent and reliable scientific evidence," typically consisting of well-designed, well-conducted clinical studies. This standard is broadly consistent with FDA's requirements for adequate substantiation of promotional claims, but Solstice should be aware that FTC enforcement is an independent risk vector, particularly for consumer-directed advertising and direct-to-consumer digital marketing campaigns.
III. Pre-Clearance Promotional Restrictions
A. General Prohibition on Pre-Clearance Promotion
The single most important rule governing Solstice's U.S. promotional activities during the pre-clearance period is straightforward: Solstice may not promote the Lumina CGM System in the United States prior to receiving 510(k) clearance from FDA. This prohibition is absolute, derives directly from Sections 301, 501(f), and 502 of the FD&C Act, and applies to all forms of promotional communication without exception.
The scope of this prohibition is comprehensive and extends to the following categories of activity:
• Print materials: Brochures, product catalogs, sell sheets, white papers, and any other printed materials that contain promotional claims about the Lumina CGM System;
• Digital content: Website pages, landing pages, blog posts, email marketing campaigns, online advertisements, and any other digital content that promotes the device;
• Broadcast media: Television advertisements, radio spots, video advertisements, and podcast sponsorships;
• Trade shows and conferences: Promotional booth displays, product demonstrations, sample distributions, and promotional presentations at medical device trade shows and healthcare industry conferences held in the United States;
• Sales representative activity: Detailing, promotional conversations with healthcare professionals, distribution of promotional materials, and any other sales-oriented interactions conducted by SBI employees or contracted sales representatives;
• Press releases: Corporate press releases that contain promotional claims about the device's performance, features, or anticipated availability;
• Investor presentations: Investor pitch decks, earnings presentations, and communications with securities analysts that contain promotional product claims (as distinguished from factual statements about regulatory status, which are permissible with appropriate disclaimers);
• Social media: Posts on corporate or employee social media accounts (Westmark Health IT, Westvale Solutions, Northpoint Services Inc., Kestrel Services Inc., Dunmore & Co., Crowne Albany Partners LLC, and any other social media platform) that contain promotional claims about the device; and
• Any other communication: Any other form of communication that directly or indirectly promotes the Lumina CGM System for commercial distribution in the United States.
The fact that the Lumina CGM System has received CE marking and has been commercially available in the European Union since September 2024 does not authorize any promotional activity in the United States. EU marketing authorization and U.S. FDA clearance are independent regulatory requirements, and the existence of one has no bearing on the other. We emphasize this point because, in our experience, companies that market devices in foreign jurisdictions prior to U.S. clearance frequently encounter difficulty maintaining a clear separation between foreign-market promotional activities and U.S.-directed communications — a risk that is discussed in detail in Section III.D below.
B. Permitted Pre-Clearance Activities
While the prohibition on pre-clearance promotion is broad, certain categories of activity are generally recognized as permissible during the pre-clearance period, provided they are conducted within appropriate boundaries and do not cross the line into promotional activity. These include:
Scientific exchange at medical conferences and in peer-reviewed publications. Solstice may present pre-clinical and clinical data relating to the Lumina CGM System at scientific conferences (e.g., the American Diabetes Association Scientific Sessions, the Diabetes Technology Society annual meeting, or the Advanced Technologies & Treatments for Diabetes conference) and publish such data in peer-reviewed scientific journals. However, such presentations and publications must be balanced, scientifically rigorous, non-promotional in character, and clearly identified as relating to a device that has not been cleared by the FDA for commercial distribution in the United States. Presentations should include a prominent disclaimer substantially in the form of: "The Solstice Lumina™ CGM System is an investigational device and has not been cleared or approved by the U.S. Food and Drug Administration. It is not available for commercial distribution in the United States."
Clinical data from the LUMINA-US pivotal study (Protocol SBD-LUM-CL-001), which is anticipated to enroll approximately 350 subjects across six U.S. clinical investigation sites, may be presented at scientific conferences and in peer-reviewed publications, provided the presentations are non-promotional and include the disclaimers described above. Such presentations should focus on the scientific and clinical data itself rather than on commercial attributes of the product (e.g., pricing, availability, competitive positioning).
Responding to unsolicited requests for information. When healthcare professionals independently and without solicitation request information about the Lumina CGM System, Solstice may respond to such requests with factual, balanced, non-promotional information about the device, consistent with FDA's draft guidance on responding to unsolicited requests. Unsolicited requests must be genuinely unsolicited — Solstice may not engineer or prompt requests from healthcare professionals as a mechanism for circumventing the prohibition on pre-clearance promotion. Responses should be provided by Solstice's medical affairs function (rather than its commercial or sales teams), should be limited in scope to the specific information requested, and should include a disclaimer regarding the device's U.S. regulatory status.
Investor communications. Solstice may make factual statements to investors, securities analysts, and the financial community about the regulatory status of the Lumina CGM System, its anticipated regulatory timeline, and the general nature of its intended use. Such statements are a necessary and appropriate component of corporate disclosure obligations, particularly if Solstice or any affiliated entity is a reporting company under applicable securities laws. However, investor communications must clearly state that the Lumina CGM System has not been cleared by FDA and is not available for commercial distribution in the United States. Investor communications should avoid promotional language, performance claims, competitive comparisons, or any other content that could be construed as promoting the device for commercial sale.
Internal training materials. Solstice and SBI may develop and distribute internal training materials to employees for the purpose of familiarizing them with the Lumina CGM System's technology, design, intended use, and regulatory strategy. Such materials must be clearly designated for internal use only and may not be distributed externally to healthcare professionals, customers, investors, or members of the public.
C. Risk of Pre-Clearance Promotional Violations
FDA actively monitors for pre-clearance promotional activity and has a robust enforcement program in this area. The consequences of pre-clearance promotional violations can be severe and include:
Warning Letters and Untitled Letters. FDA routinely issues Warning Letters and Untitled Letters to companies that engage in the promotion of uncleared medical devices. Warning Letters are public documents that are posted on FDA's website, and they identify the specific violations, demand corrective action, and warn of potential further enforcement. Receipt of a Warning Letter can cause significant reputational harm, delay regulatory submissions, and complicate relationships with healthcare customers and distribution partners.
Seizure and injunction. Under Sections 304 and 302 of the FD&C Act, FDA may seek judicial seizure of adulterated or misbranded devices and may obtain injunctive relief prohibiting continued violations. In the context of pre-clearance promotion, injunctive relief could include court orders requiring the removal of promotional materials, cessation of marketing activities, and issuance of corrective communications.
Criminal prosecution. Violations of Section 301 of the FD&C Act are subject to criminal penalties, including fines and imprisonment. While criminal prosecution for pre-clearance promotional violations is less common than administrative enforcement, it remains a possibility, particularly in cases involving egregious or willful violations.
Recent enforcement precedent. FDA has issued numerous Warning Letters in recent years addressing pre-clearance promotion of medical devices, including several cases involving digital health and diagnostic devices marketed through online platforms prior to obtaining required FDA clearance. These enforcement actions underscore the seriousness with which FDA views this issue and the Agency's willingness to take action even where the promotional activity occurs predominantly in digital channels.
Recommendation: In light of these enforcement risks, we strongly recommend that all external-facing communications — including website content, social media posts, press releases, investor presentations, conference materials, and any other communications accessible to U.S. audiences — be reviewed by Calderwood & Harkness prior to dissemination to ensure compliance with pre-clearance promotional restrictions. This review process should be formalized through the establishment of an internal review and approval workflow, as described in Section VIII.A below.
D. EU Marketing Activity and U.S. Spillover
Solstice has been actively marketing the Lumina CGM System in the European Union since September 2024, following receipt of CE marking. This EU marketing activity creates a significant risk of "spillover" into the United States — that is, the risk that EU-directed promotional materials and marketing content are accessible to U.S. audiences via the internet and could be construed by FDA as constituting U.S.-directed promotion of an uncleared device.
This risk is not hypothetical. The internet is inherently borderless, and digital content intended for EU audiences is typically accessible to anyone with an internet connection, regardless of geographic location. EU-facing promotional websites, social media posts, Crowne Albany Partners LLC videos, and online advertisements may be viewed by U.S. healthcare professionals, patients, and consumers. If such content contains promotional claims about the Lumina CGM System — as it undoubtedly does, given that the device is being commercially promoted in the EU — and those claims are accessible to U.S. audiences, FDA may take the position that Solstice is engaged in U.S.-directed promotion of an uncleared device.
To mitigate this risk, we recommend the following measures:
1. Geo-fencing or geo-targeting of EU promotional content. Solstice should implement geo-fencing or geo-targeting technology on its EU-facing promotional websites and digital advertising campaigns to restrict access from U.S.-based IP addresses. While geo-fencing is not a perfect solution (users may employ VPNs or proxy servers to circumvent geographic restrictions), it demonstrates good faith efforts to limit U.S. access to EU promotional content and may serve as a mitigating factor in the event of an FDA inquiry.
2. Disclaimers on EU-facing websites. All EU-facing promotional websites for the Lumina CGM System should include a prominent disclaimer — visible upon initial page load or through a geographic acknowledgment interstitial — stating that the product is CE-marked for sale in the European Union and is not cleared by the FDA for sale or distribution in the United States. A suggested form of disclaimer is: "The Solstice Lumina™ CGM System is CE-marked and available for sale in the European Union. It has not been cleared or approved by the U.S. Food and Drug Administration and is not available for sale or distribution in the United States."
3. Separation of EU and U.S. website domains. Solstice should maintain separate website domains or clearly delineated website sections for EU and U.S. audiences. The EU promotional website should operate on a distinct domain (e.g., lumina-cgm.eu or lumina.solstice-biomedical.eu) that is clearly separate from SBI's U.S. corporate website (associated with the SBI offices at 220 Westbrook Drive, Suite 400, Cambridge, MA 02142). Cross-linking between the EU promotional site and the U.S. corporate site should be avoided or carefully controlled to prevent U.S. users from inadvertently navigating to EU promotional content.
4. Social media geographic disclaimers. Solstice's EU-based social media accounts should include geographic identifiers in their profiles (e.g., "Solstice Biomedical – Europe") and should include disclaimers in their bios or profile descriptions indicating that the promoted products are available in the EU and are not cleared for sale in the U.S. Where platform functionality permits, Solstice should use geographic targeting to limit the audience for EU promotional social media posts to EU-based users.
5. Training of EU marketing personnel. Solstice's EU marketing team should receive specific training on U.S. pre-clearance promotional restrictions and the risk of U.S. spillover from EU marketing activities. EU marketing personnel should understand that their activities, even if directed at EU audiences, may have U.S. regulatory implications and should be designed to minimize U.S. exposure. This training should be documented and refreshed periodically.
IV. Post-Clearance Promotional Framework
A. Cleared Indications for Use as the Boundary
Upon receipt of 510(k) clearance, which is targeted for Q3 2026, Solstice will be permitted to promote the Lumina CGM System in the United States — but only within the boundaries established by the device's cleared indications for use. The cleared indications for use, as stated on FDA Form 3881 and reflected in the cleared labeling, define the permissible scope of promotional activity. All promotional claims must be consistent with, and supported by, the cleared labeling.
Based on current regulatory planning, the draft indications for use for the Lumina CGM System are as follows:
• Continuous glucose monitoring in persons aged 18 years and older;
• Indicated for the management of Type 1 or Type 2 diabetes mellitus;
• Prescription use only;
• Measurement range of 40–400 mg/dL;
• Sensor wear duration of 14 days (336 hours); and
• Interstitial glucose measurement in subcutaneous tissue with real-time glucose readings, trend information, and configurable alerts/alarms.
These indications establish the outer boundary of Solstice's promotional activity. Promotional claims that expand the intended use of the Lumina CGM System beyond what is stated in the cleared labeling are prohibited. For example, Solstice may not:
• Promote the Lumina CGM System for use by individuals under 18 years of age (i.e., pediatric use), unless and until a separate clearance is obtained for a pediatric indication;
• Promote the device for the management of gestational diabetes, unless gestational diabetes is specifically encompassed within the cleared indications;
• Promote the device for non-diabetic wellness monitoring, glucose tracking for athletic performance, or general metabolic health monitoring, none of which are included in the anticipated indications;
• Promote the device for use in making insulin dosing decisions, unless the cleared labeling specifically includes a non-adjunctive claim or the device is cleared under the iCGM classification pathway (discussed in Section VI.D below); or
• Promote the device for sensor wear beyond the cleared 14-day duration.
We recognize that Solstice's commercial team may perceive market opportunities in one or more of these unapproved uses. Nevertheless, any promotion of the Lumina CGM System for uses outside the cleared indications constitutes off-label promotion and exposes Solstice to the enforcement consequences described in Section VI.B below.
B. Truthful and Non-Misleading Standard
Every promotional claim made by Solstice regarding the Lumina CGM System must satisfy three fundamental requirements: (1) the claim must be truthful, (2) the claim must not be misleading, and (3) the claim must be adequately substantiated by competent and reliable scientific evidence.
Truthfulness requires that all factual assertions in promotional materials be accurate and verifiable. Promotional claims should not overstate the performance, accuracy, safety, or clinical utility of the Lumina CGM System. Quantitative performance claims are subject to particularly rigorous scrutiny and must be directly supported by the data submitted to FDA in the 510(k) and referenced in the cleared labeling.
Non-misleadingness is a broader standard than truthfulness alone. A claim may be literally true yet still misleading if it omits material information, creates a false impression, or presents data in a manner that distorts its significance. For example, presenting MARD data from a subset of study subjects without disclosing that the overall population MARD was higher could be misleading, even if the subset-specific data is accurate. Similarly, emphasizing favorable performance metrics while omitting or downplaying less favorable results may render promotional materials misleading.
Adequate substantiation requires that each promotional claim be supported by competent and reliable scientific evidence. For quantitative performance claims, this typically means clinical data from well-designed, well-conducted studies. The following specific performance claims may be included in promotional materials post-clearance, subject to the conditions noted:
• MARD (Mean Absolute Relative Difference): Solstice has established a target MARD of ≤ 9.0% for the Lumina C14 sensor. If this target is achieved in the LUMINA-US pivotal clinical study (Protocol SBD-LUM-CL-001, approximately 350 subjects across six U.S. clinical investigation sites), and the MARD result is reflected in the cleared labeling, Solstice may reference the actual MARD figure in post-clearance promotional materials. However, the MARD claim must accurately reflect the actual study results — if the achieved MARD is, for example, 8.7%, the promotional claim must state 8.7% (or a properly rounded figure) rather than an aspirational or rounded-down figure. The MARD claim should specify the comparator method (e.g., YSI laboratory reference glucose), the number of paired data points, and the study population characteristics, either in the promotional material itself or in a referenced source.
• Consensus Error Grid Performance: Solstice has established a target of ≥ 99% of readings in Clarke or Consensus Error Grid Zones A and B. As with the MARD claim, this claim may be made post-clearance only if the actual clinical study results support it and the data is reflected in the cleared labeling. The claim should specify the applicable error grid methodology and reference the underlying study.
• Sensor Wear Duration: A claim that the Lumina C14 sensor has a 14-day (336-hour) wear duration is permissible post-clearance if this specification is consistent with the cleared labeling. The claim should not imply that the sensor will necessarily function accurately for the entire 14-day period if the clinical data indicates meaningful accuracy degradation toward the end of the wear period.
• Measurement Range: A claim that the Lumina CGM System provides glucose measurements across a range of 40–400 mg/dL is permissible if consistent with the cleared labeling.
• Warm-Up Time: A claim that the Lumina C14 sensor has a warm-up time of ≤ 60 minutes is permissible if consistent with the cleared labeling and supported by performance testing data.
• Alert Latency: A claim that the Lumina CGM System provides glucose alerts with a latency of ≤ 5 minutes is permissible if consistent with the cleared labeling and supported by clinical or bench testing data.
In all cases, promotional claims should reference the underlying data source and should be consistent with the manner in which the data is presented in the cleared labeling. Solstice should avoid "cherry-picking" favorable data points or presenting data out of context.
C. Required Fair Balance
A fundamental requirement of FDA-compliant promotional materials is the inclusion of "fair balance" — that is, adequate information about the risks, contraindications, warnings, and precautions associated with the Lumina CGM System. Promotional materials that emphasize the benefits of the device while omitting or minimizing risk information are inherently misleading and may constitute misbranding under Section 502 of the FD&C Act.
The fair balance requirement is derived from multiple regulatory provisions, including Section 502(a) (misbranding for misleading labeling), Section 502(f) (requirement for adequate directions for use and warnings), and 21 C.F.R. Part 801 (device labeling regulations). Under 21 C.F.R. Part 801, promotional materials that constitute labeling must include, or be accompanied by, a brief summary of the device's intended use, contraindications, warnings, precautions, and adverse events, or must include adequate directions for use.
For the Lumina CGM System, fair balance disclosures should include, at a minimum, the following categories of information (subject to the specific content of the cleared labeling):
• Contraindications: Any conditions or circumstances under which the Lumina CGM System should not be used;
• Warnings: Including, but not limited to, sensor insertion site reactions (e.g., erythema, edema, bruising, infection), potential interference from exogenous substances (e.g., acetaminophen, ascorbic acid, or other substances that may affect sensor accuracy), limitations on use in specific clinical settings (e.g., critically ill patients), and MRI incompatibility or conditional compatibility, as applicable;
• Precautions: Including limitations on sensor placement sites, proper insertion technique, instructions for sensor replacement at the end of the wear period, and the requirement for confirmatory fingerstick blood glucose measurements in certain circumstances (if applicable under the cleared labeling);
• Adverse events: A summary of adverse events observed in the LUMINA-US pivotal study; and
• Statement of prescription use: A clear indication that the Lumina CGM System is a prescription device and should be used under the supervision of a healthcare professional.
The presentation of fair balance information should be given comparable prominence to the presentation of efficacy and performance claims. Fair balance disclosures should not be buried in fine print, relegated to footnotes, or presented in a manner that makes them difficult to read or understand. On digital platforms and social media, fair balance information must be directly accessible — not hidden behind multiple clicks or navigation steps.
D. Claim Categories and Substantiation Requirements
Post-clearance promotional claims for the Lumina CGM System will fall into several categories, each with its own substantiation requirements:
Safety claims assert that the Lumina CGM System is safe for its intended use, that it has a favorable safety profile, or that specific safety-related characteristics have been demonstrated. Safety claims must be supported by clinical evidence from the LUMINA-US pivotal study and/or by biocompatibility testing data. Biocompatibility testing of the Lumina C14 sensor has been performed by Whitmore Laboratories Inc. in accordance with ISO 10993 series standards, and the resulting data may support claims regarding the biocompatibility of the sensor's materials and design. Any safety claims referencing specific adverse event rates or incidences must accurately reflect the data from the pivotal study and be consistent with the cleared labeling.
Efficacy and accuracy claims assert that the Lumina CGM System accurately measures interstitial glucose and provides reliable glucose readings, trend information, and alerts. These claims must be supported by MARD data, consensus error grid analysis, and other performance testing results from the LUMINA-US study. As noted in Section IV.B, quantitative performance claims (e.g., specific MARD percentages, error grid zone distributions) must precisely reflect the actual study data and may not be inflated or rounded favorably.
Superiority claims assert that the Lumina CGM System is superior to one or more competing products in terms of accuracy, safety, wear duration, user experience, or any other attribute. Superiority claims are subject to heightened scrutiny and must be supported by adequate comparative data — typically head-to-head clinical studies or well-designed analytical comparisons. General superiority claims (e.g., "the most accurate CGM available") are prohibited in the absence of adequate comparative substantiation. The specific challenges associated with comparative advertising are addressed in detail in Section V below.
Design and technology claims relate to the technical features and design characteristics of the Lumina CGM System, such as the PtIr-4G electrode coating technology employed in the Lumina C14 sensor, the BLE 5.2 wireless connectivity between the C14 sensor and R7 reader, and the LuminaPredict v2.1 predictive glucose algorithm. Such claims are generally permissible if they are factual, non-misleading, and accurately describe the device's technical specifications. However, Solstice must exercise caution to avoid implying that a particular design feature or technology translates into clinical superiority without adequate clinical substantiation. For example, a claim that the Lumina C14 sensor employs PtIr-4G electrode coating technology is a factual design claim; a claim that the PtIr-4G electrode coating provides "the most accurate glucose readings" is a clinical superiority claim that requires substantiation.
Duration claims relating to the 14-day sensor wear duration are permissible if consistent with the cleared labeling. Solstice should avoid making claims or implications that the sensor may be safely or effectively worn beyond the 14-day labeled duration.
Convenience and user experience claims relating to the Lumina R7 arm-worn reader/transmitter form factor, real-time glucose display, trend arrows, 8-hour trend graphs, and configurable alerts are generally permissible if they accurately and non-misleadingly describe the features of the cleared device. Claims about "ease of use," "comfort," or "convenience" should be supported by user experience data or should be clearly identified as subjective characterizations rather than clinical claims.
V. Comparative Advertising Limitations
A. General Principles of Comparative Advertising for Medical Devices
Comparative advertising — promotional material that explicitly or implicitly compares the advertised device to a competing product — is not prohibited per se under FDA regulations or the FD&C Act. However, comparative advertising is subject to heightened scrutiny for truthfulness, non-misleadingness, and adequate substantiation, and it carries significant legal risks, including potential liability under both FDA enforcement authority and the Lanham Act (discussed in Section V.C below).
The overarching principle is that any comparative claim must be truthful, non-misleading, and supported by adequate and appropriate evidence. For performance-related comparisons (e.g., accuracy, safety, durability), this typically requires head-to-head clinical data from a well-designed comparative study, or, at a minimum, well-designed analytical comparisons performed under substantially equivalent conditions. Comparisons based on data from separate, non-contemporaneous studies are generally disfavored because differences in study design, patient populations, endpoints, and analytical methods may confound the comparison and render it misleading.
Implied comparisons — that is, promotional claims that suggest superiority without naming a specific comparator product — are subject to the same substantiation requirements as explicit comparisons. For example, a claim that the Lumina CGM System offers "the longest sensor wear duration" or "unmatched accuracy" implies superiority over all competing products and must be substantiated as such.
Solstice should be aware that comparative advertising disputes in the medical device industry are not uncommon and can result in costly and protracted litigation, reputational damage, and regulatory scrutiny. Our strong recommendation, as set forth in detail below, is that Solstice adopt a conservative approach to comparative advertising and focus its marketing efforts on the Lumina CGM System's own cleared specifications and performance data rather than on direct comparisons to competing products.
B. Comparisons to NovaSense GlucoTrack Products
Solstice's competitive landscape in the U.S. CGM market is significantly defined by NovaSense Medical Technologies Inc. ("NovaSense"), a San Diego-based medical device company headquartered at 4800 Innovation Parkway, San Diego, California 92121. NovaSense is a substantial competitor with fiscal year 2024 revenues of approximately $1.24 billion, under the leadership of Chief Executive Officer David Reinhardt. NovaSense manufactures and markets the GlucoTrack product line, which includes the GlucoTrack NX-500 and the GlucoTrack NX-700.
The NovaSense GlucoTrack NX-500 has been identified as the primary predicate device for SBI's 510(k) submission. The NX-500 was cleared by FDA under 510(k) No. K211034 on June 18, 2022. The NovaSense GlucoTrack NX-700, cleared under 510(k) No. K230489 on March 7, 2024, serves as a secondary predicate and reference device. The use of NovaSense products as predicate devices in the 510(k) substantial equivalence comparison is a purely regulatory exercise; it does not authorize or provide a basis for promotional comparisons to NovaSense products.
Solstice's commercial team may be tempted to highlight certain differences between the Lumina CGM System and the GlucoTrack NX-500 as competitive advantages. Based on the current technical specifications and regulatory filings, these differences include:
While these differences may represent genuine differentiators in the marketplace, the use of such differences in comparative advertising is subject to significant restrictions:
Sensor wear duration comparison. A claim that the Lumina CGM System offers "longer wear time than GlucoTrack" or "14 days vs. 10 days" is a factual comparison of labeled specifications. Such a comparison may be permissible if (a) both products' cleared labeling specifies the respective wear durations, (b) the comparison is presented accurately and without embellishment, and (c) the comparison does not imply clinical superiority (e.g., that a longer wear duration translates into better glycemic outcomes) without adequate substantiation. However, even a seemingly straightforward factual comparison carries risk and should be reviewed on a case-by-case basis with legal counsel. Furthermore, NovaSense may update its product line or obtain clearance for an extended-wear sensor, which would render the comparison inaccurate or outdated.
Accuracy comparison. A claim that the Lumina CGM System is "more accurate than GlucoTrack" — or any words to similar effect — requires head-to-head comparative clinical data demonstrating a statistically significant and clinically meaningful difference in accuracy (e.g., MARD). To our knowledge, no such head-to-head study has been conducted or is currently planned. In the absence of such data, accuracy-based comparative claims are unsupported and should not be made.
Technology comparison. Claims that the Lumina CGM System employs "better technology" or has a "superior sensor" are subjective superiority claims that require adequate clinical substantiation. Factual descriptions of Solstice's proprietary technology (e.g., "The Lumina C14 sensor employs PtIr-4G electrode coating technology") are permissible as standalone claims, but should not be presented in a comparative context that implies clinical superiority over NovaSense's technology without supporting data.
General superiority claims. Broad, unqualified claims such as "the best CGM available," "the most advanced glucose monitoring technology," or "superior to all other CGMs" are inherently comparative, require comprehensive substantiation against all competing products, and should be avoided.
Competitive risk. NovaSense is a well-resourced competitor with sophisticated patent and intellectual property counsel. NovaSense's patent counsel is the firm of Marlowe Asset Management Patent Group LLP, led by partner Patricia Langford. NovaSense has both the resources and the legal infrastructure to pursue aggressive action against competitors that make false or misleading comparative advertising claims. In addition to potential FDA enforcement, NovaSense could pursue private litigation under the Lanham Act (discussed in Section V.C below) and state unfair competition statutes.
Recommendation: We strongly recommend that Solstice avoid direct comparative claims that reference NovaSense, GlucoTrack, or any other specific competing product by name. Instead, Solstice should focus its marketing efforts on the Lumina CGM System's own cleared specifications, performance data, and clinical evidence. This approach minimizes the risk of Lanham Act litigation, FDA enforcement action, and competitive retaliation while still allowing Solstice to effectively communicate the value proposition of its product. If Solstice determines that comparative advertising is commercially necessary, all such materials must receive heightened legal review from Calderwood & Harkness and must be supported by adequate substantiating evidence.
C. Lanham Act Liability for False Advertising
Section 43(a) of the Lanham Act, codified at 15 U.S.C. § 1125(a), provides a private right of action for any person who believes that he or she is or is likely to be damaged by a false or misleading description of fact, or a false or misleading representation of fact, used in commercial advertising or promotion. Unlike FDA enforcement, which is initiated by a government agency, Lanham Act claims are brought by private parties — typically competitors — in federal court.
NovaSense Medical Technologies Inc. would have standing to bring a Lanham Act claim against Solstice if Solstice makes false or misleading comparative advertising claims regarding NovaSense's products. To prevail on a Lanham Act false advertising claim, NovaSense would need to establish that: (1) Solstice made a false or misleading statement of fact in commercial advertising; (2) the statement actually deceived or had the tendency to deceive a substantial segment of its audience; (3) the deception was material, in that it was likely to influence purchasing decisions; (4) the advertised goods traveled in interstate commerce; and (5) NovaSense has been or is likely to be injured as a result of the false advertising.
The remedies available in a Lanham Act false advertising action are substantial and include:
• Injunctive relief: A court may issue a preliminary or permanent injunction requiring Solstice to cease the challenged advertising and, in some cases, to issue corrective advertising;
• Monetary damages: NovaSense may recover its actual damages, including lost profits and damage to goodwill, or, alternatively, Solstice's profits attributable to the false advertising;
• Enhanced damages and attorneys' fees: In cases of willful or egregious false advertising, courts may award enhanced damages (up to three times actual damages) and attorneys' fees to the prevailing party; and
• Costs of the action.
In addition to federal Lanham Act liability, Solstice faces potential exposure under state unfair competition laws. Given NovaSense's headquarters in San Diego, California, NovaSense could bring claims under California Business and Professions Code § 17200 et seq. (the California Unfair Competition Law), which provides broad remedies for unlawful, unfair, or fraudulent business acts or practices, including false advertising. California's UCL permits actions by competitors and, in certain circumstances, by the California Attorney General or district attorneys.
The combined risks of Lanham Act litigation and state unfair competition claims further support our recommendation that Solstice adopt a conservative approach to comparative advertising and avoid direct references to NovaSense or GlucoTrack products in its promotional materials.
VI. Off-Label Promotion Risks
A. Definition and Scope
"Off-label" promotion refers to the promotion of a medical device for uses, indications, patient populations, or conditions that are not included in the device's FDA-cleared labeling. While healthcare professionals are free to use cleared medical devices for off-label purposes based on their independent medical judgment, manufacturers are prohibited from promoting their devices for off-label uses. This distinction — between the freedom of healthcare professionals to prescribe and the obligation of manufacturers to promote only within cleared labeling — is a cornerstone of FDA's regulatory framework.
For the Lumina CGM System, the following activities would constitute off-label promotion if conducted by Solstice or its agents:
Promoting for pediatric use. The anticipated cleared indication is limited to persons aged 18 years and older. Promoting the Lumina CGM System for use in children or adolescents — whether through marketing materials directed at pediatric endocrinologists, advertisements featuring images of children using the device, or social media content implying suitability for pediatric patients — would constitute off-label promotion.
Promoting for gestational diabetes. Unless gestational diabetes is specifically included within the cleared indications for use, promoting the Lumina CGM System for glucose monitoring during pregnancy or for the management of gestational diabetes would constitute off-label promotion.
Promoting for non-diabetic wellness monitoring or athletic performance. The consumer wellness and fitness monitoring market represents a significant commercial opportunity, and Solstice may face pressure to position the Lumina CGM System for use by non-diabetic individuals interested in tracking their glucose levels for general wellness, dietary optimization, or athletic performance purposes. However, the anticipated cleared indications are limited to persons with Type 1 or Type 2 diabetes mellitus, and promoting the device for non-diabetic use would be off-label.
Promoting for insulin dosing decisions (absent appropriate labeling). If the Lumina CGM System is not cleared with non-adjunctive labeling — that is, if the cleared labeling requires users to perform confirmatory fingerstick blood glucose measurements before making treatment decisions — then promoting the device for use in making insulin dosing decisions without confirmatory testing would constitute off-label promotion. This issue is closely related to the iCGM classification considerations discussed in Section VI.D below.
Promoting for extended sensor wear. The anticipated cleared labeling specifies a maximum sensor wear duration of 14 days (336 hours). Promoting the use of the Lumina C14 sensor beyond this period — whether through explicit claims or through implied endorsements (e.g., social media posts by sponsored influencers describing extended wear) — would constitute off-label promotion.
B. Enforcement Consequences
The enforcement consequences for off-label promotion are severe and multifaceted, extending well beyond the FDA enforcement actions described in Section III.C above:
FDA enforcement. FDA may issue Warning Letters, Untitled Letters, or consent decrees addressing off-label promotional activity. In cases of repeated or egregious violations, FDA may pursue injunctive relief or criminal prosecution.
Department of Justice prosecution. The U.S. Department of Justice ("DOJ") has prosecuted numerous cases involving off-label promotion of medical products under the FD&C Act's misbranding provisions. Convictions may result in substantial criminal fines and, in some cases, imprisonment of responsible corporate officers.
False Claims Act exposure. Off-label promotion creates significant exposure under the federal False Claims Act, 31 U.S.C. §§ 3729–3733, if off-label promotion leads healthcare providers to submit claims for reimbursement to federal healthcare programs (Medicare, Medicaid, TRICARE, etc.)