PRIVILEGED AND CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION
CALDERWOOD & HARKNESS LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005
MEMORANDUM
April 28, 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, Responsible Partner, Calderwood & Harkness LLP
Sean Morrissey, Working Associate, Calderwood & Harkness LLP
RE:
U.S. Establishment Registration and Device Listing Requirements Under 21 C.F.R. Part 807 — Solstice Biomedical Inc. and the Solstice Lumina™ CGM System
ENGAGEMENT REF.: 1037-00002
This memorandum constitutes a privileged and confidential attorney-client communication. It is prepared solely for the use of the addressees and other authorized representatives of Solstice Biomedical Devices Ltd. and Solstice Biomedical Inc. Any distribution, copying, or disclosure to third parties without the prior written consent of Calderwood & Harkness LLP is strictly prohibited.
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I. PURPOSE AND SCOPE
This memorandum has been prepared by Calderwood & Harkness LLP ("C&H") to advise Solstice Biomedical Devices Ltd. ("Solstice," "SBD," or the "Company"), an Irish-headquartered private limited company incorporated under the laws of Ireland (Companies Registration Office No. 648231), and its wholly owned U.S. subsidiary, Solstice Biomedical Inc. ("SBI"), a corporation organized and existing under the laws of the State of Delaware (Secretary of State File No. 7834291), on the establishment registration and device listing obligations arising under 21 C.F.R. Part 807 that are applicable to the planned U.S. market entry of the Solstice Lumina™ Continuous Glucose Monitoring ("CGM") System.
SBI, which maintains its principal offices at 220 Westbrook Drive, Suite 400, Cambridge, Massachusetts 02142, is intended to serve a dual role in connection with the Lumina CGM System's U.S. commercialization: first, as the designated U.S. agent for the foreign manufacturer (SBD) under 21 C.F.R. § 807.40(a); and second, as the intended holder of the 510(k) premarket notification clearance that will authorize the Lumina CGM System for commercial distribution in the United States. This dual capacity is common among U.S. subsidiaries of foreign medical device manufacturers and carries with it distinct regulatory obligations that must be carefully coordinated.
This memorandum addresses the following topics in detail:
(a) initial establishment registration for SBI as a domestic establishment and for SBD as a foreign establishment;
(b) annual registration renewal procedures and deadlines for both establishments;
(c) device listing requirements applicable to the Solstice Lumina™ C14 implantable sensor and the Solstice Lumina™ R7 wearable reader/transmitter device, as well as the potential need to update or amend the existing listing for the GlucoStrip RX-200 Test Strip Reader;
(d) U.S. agent designation requirements for SBD as a foreign establishment, including the identification of the appropriate designee and contact person; and
(e) practical guidance on FDA Unified Registration and Listing System ("FURLS") submission procedures through the Device Registration and Listing Module ("DRLM"), including account setup, data entry, fee payment, and common pitfalls.
This memorandum should be read in context with the broader regulatory timeline governing SBI's U.S. market entry strategy for the Lumina CGM System. As currently planned, that timeline contemplates the following key milestones: submission of a traditional 510(k) premarket notification to the U.S. Food and Drug Administration ("FDA") targeted for April 30, 2026; receipt of FDA clearance targeted for the third quarter of 2026; and U.S. commercial launch of the Lumina CGM System targeted for the fourth quarter of 2026. The registration and listing obligations discussed herein must be completed in coordination with these milestones, as described more fully in Section IX below.
This memorandum does not address the substantive requirements for 510(k) clearance, the Quality System Regulation (21 C.F.R. Part 820), Medical Device Reporting (21 C.F.R. Part 803), labeling requirements (21 C.F.R. Part 801), or other post-clearance regulatory obligations, each of which is or will be covered in separate memoranda prepared by C&H in connection with this engagement. References to those related topics are included herein only to the extent necessary to provide context for the registration and listing discussion.
II. EXECUTIVE SUMMARY
The following summarizes the principal conclusions and recommendations set forth in this memorandum:
Domestic Registration (SBI). SBI must register as a domestic establishment with FDA prior to commencing commercial distribution of the Solstice Lumina™ CGM System in the United States. SBI's anticipated activities — including receiving imported finished devices from SBD's Dublin manufacturing facility, warehousing, labeling, and distributing those devices to U.S. customers — constitute "manufacturing" activities within the meaning of 21 C.F.R. Part 807 and therefore trigger registration obligations. Registration must be submitted electronically through FDA's FURLS/DRLM portal.
Foreign Registration (SBD). SBD, as the foreign manufacturer of the Lumina CGM System at its facility located at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland, must separately register as a foreign establishment with FDA. Foreign establishment registration is governed by the same regulatory framework as domestic registration but carries the additional requirement that the foreign establishment designate a U.S. agent who resides or maintains a place of business in the United States.
U.S. Agent Designation. SBI is the appropriate entity to serve as the U.S. agent for SBD under 21 C.F.R. § 807.40(a). We recommend that SBI be formally designated as SBD's U.S. agent in the FURLS submission, with Marcus Hale, Vice President of U.S. Operations, identified as the named individual contact person. The U.S. agent serves as the point of contact between FDA and the foreign establishment for all communications concerning device listing, registration, and related regulatory matters, and must be a real person who is accessible during normal business hours — the role cannot be fulfilled by a mailbox, answering machine, or answering service.
Electronic Submission. Both the domestic and foreign establishment registrations, as well as all device listings, must be submitted electronically through FDA's FURLS/DRLM portal, accessible at https://www.access.fda.gov. This will require the creation of FDA Industry Systems ("FIS") accounts for both SBI and SBD.
Prior Registration Status. SBI has existing FDA interaction history. Solstice previously obtained 510(k) clearance for the GlucoStrip RX-200 Test Strip Reader (510(k) No. K192847, cleared November 14, 2019, product code NBW, Class II). It is critical to confirm at the outset whether SBI or SBD was the holder of that clearance and whether SBI currently maintains an active establishment registration arising from that prior clearance. If the registration has lapsed — for example, due to failure to renew during a prior October 1 – December 31 renewal window — a new initial registration will be required. C&H recommends that Marcus Hale verify SBI's current FURLS registration status as a first priority action item.
MDUFA Fees. Both establishments will be subject to annual establishment registration fees under the Medical Device User Fee Amendments ("MDUFA"). As discussed in Section IV.E below, SBI does not qualify for the small business fee reduction because the consolidated global revenues of SBD, as the parent entity, exceed the applicable MDUFA small business threshold.
Timing. Establishment registration and device listing are prerequisites to lawful commercial distribution of medical devices in the United States. However, they are not prerequisites to the filing of a 510(k) premarket notification. Accordingly, while registration does not need to be completed prior to the targeted 510(k) submission date of April 30, 2026, the timing of registration and listing must be coordinated so that both establishments are actively registered and the Lumina CGM System components are properly listed before any distribution activity occurs following 510(k) clearance. We recommend initiating the registration process no later than 60 days before the anticipated Q4 2026 U.S. commercial launch date to allow for any FURLS processing delays or fee payment issues.
III. REGULATORY FRAMEWORK — 21 C.F.R. PART 807
A. Statutory and Regulatory Basis
The establishment registration and device listing requirements applicable to manufacturers and distributors of medical devices in the United States are rooted in Section 510 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act"), codified at 21 U.S.C. § 360. Section 510 requires, in relevant part, that every person who owns or operates any establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device intended for human use shall register such establishment with the Secretary of Health and Human Services (authority delegated to FDA) and shall list each device manufactured, prepared, propagated, compounded, or processed at that establishment.
The implementing regulations are set forth at 21 C.F.R. Part 807, which is organized into the following subparts:
• Subpart A — General Provisions (§§ 807.1–807.3), establishing scope and definitions.
• Subpart B — Procedures for Device Establishments (§§ 807.20–807.39), setting forth the requirements for registration and device listing by domestic establishments, including timing, information requirements, and procedures for updates.
• Subpart C — Procedures for Foreign Device Establishments (§§ 807.40–807.41), addressing the additional requirements applicable to foreign manufacturers exporting devices to the United States, including the obligation to designate a U.S. agent.
• Subpart D — [Reserved].
• Subpart E — Premarket Notification Procedures (§§ 807.81–807.100), setting forth the 510(k) premarket notification procedures. While Subpart E is directly relevant to the Lumina CGM System's 510(k) submission, it is addressed in separate memoranda; only the interrelationship between premarket notification and establishment registration is discussed herein.
In addition to these binding regulations, FDA has issued several guidance documents that inform the practical application of Part 807, including guidance on the use of the FURLS/DRLM electronic submission system, guidance on annual registration renewal procedures, and frequently asked questions regarding the scope of the registration obligation. While FDA guidance documents do not establish legally binding obligations, they represent the Agency's current thinking on regulatory interpretation and enforcement priorities and should be considered in planning the registration and listing process.
B. Who Must Register
Under 21 C.F.R. § 807.20(a), owners or operators of establishments that are engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of devices intended for commercial distribution in the United States are required to register with FDA. The registration obligation applies to each physical establishment at which such activities are conducted, meaning that a single corporate entity may be required to register multiple establishments if it conducts covered activities at more than one location.
The term "manufacture" is defined broadly under FDA regulations and the FD&C Act. It encompasses not only the fabrication and assembly of finished devices but also a wide range of ancillary activities, including:
• design and development activities;
• fabrication, assembly, and processing of device components and finished devices;
• labeling and packaging of devices;
• repackaging and relabeling of devices;
• sterilization of devices;
• installation of devices (in certain circumstances); and
• activities performed by contract manufacturers, contract sterilizers, and specification developers acting on behalf of a device manufacturer.
Critically, the registration obligation extends to both domestic establishments and foreign establishments that export devices to the United States. In the context of the Lumina CGM System, both SBI and SBD have registration obligations, though the specific nature of their obligations differs based on their respective roles and locations:
• SBI (Domestic Establishment): SBI's anticipated activities in the United States include receiving imported finished and semi-finished Lumina CGM System components from SBD's Dublin manufacturing facility, warehousing those components at the Cambridge, Massachusetts facility, applying or verifying U.S.-specific labeling, and distributing the finished devices to U.S. healthcare providers, distributors, and end users. These activities — particularly labeling, warehousing with intent to distribute, and initial distribution — constitute "manufacturing" activities within the meaning of 21 C.F.R. Part 807 and trigger the obligation to register as a domestic establishment.
• SBD (Foreign Establishment): SBD's activities in Ireland include the design, development, fabrication, assembly, processing, testing, and packaging of the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter device. As the entity performing primary manufacturing of devices intended for export to and commercial distribution in the United States, SBD must register as a foreign establishment under 21 C.F.R. § 807.40.
C. Exemptions and Exceptions
The regulations provide limited exemptions from the registration requirement for certain categories of entities. Under 21 C.F.R. § 807.20(b) and (c), the following are generally exempt from registration:
• licensed practitioners (including physicians, dentists, and optometrists) who manufacture or otherwise alter devices solely for use in their professional practice;
• pharmacies, retail establishments, and other entities that do not manufacture or alter devices but merely sell or distribute finished devices at retail;
• persons who only distribute devices under their own name without any additional manufacturing, repackaging, or relabeling activity; and
• certain entities engaged exclusively in the manufacture of devices intended solely for veterinary use.
None of these exemptions apply to SBI or SBD. SBI will perform labeling, warehousing, and initial distribution activities that constitute "manufacturing" under the regulation, and SBD is the primary manufacturer of the Lumina CGM System components. Accordingly, both entities are subject to the full registration and listing obligations under Part 807.
IV. DOMESTIC ESTABLISHMENT REGISTRATION — SOLSTICE BIOMEDICAL INC.
A. Registration Obligation
SBI, as the domestic entity responsible for importing, labeling, warehousing, and distributing the Solstice Lumina™ CGM System in the United States, must register its establishment with FDA. The establishment to be registered is located at 220 Westbrook Drive, Suite 400, Cambridge, Massachusetts 02142, which serves as SBI's principal place of business and the facility at which SBI will conduct its device-related activities.
As discussed in Section III.B above, SBI's anticipated activities — receiving imported devices from SBD's Dublin facility, warehousing those devices pending distribution, applying or verifying U.S.-market labeling (including the Lumina CGM System's instructions for use, patient guides, and packaging), and distributing finished devices to authorized customers — collectively constitute "manufacturing" activities within the broad meaning of 21 C.F.R. Part 807. Each of these activities independently triggers the obligation to register the establishment at which the activity is performed.
It is important to note that SBI has prior FDA interaction history arising from the company's involvement with the GlucoStrip RX-200 Test Strip Reader, which received 510(k) clearance on November 14, 2019, under 510(k) No. K192847 (product code NBW, Class II). That prior clearance may have been obtained with SBI as the 510(k) holder, and the clearance process may have involved a prior establishment registration for SBI's Cambridge, Massachusetts facility. C&H recommends that SBI promptly confirm the following:
(i) whether SBI or SBD was the holder of 510(k) No. K192847;
(ii) whether SBI's Cambridge facility is currently registered as an active establishment in FURLS;
(iii) if previously registered, whether the registration has been timely renewed during each annual October 1 – December 31 renewal window since the initial registration; and
(iv) whether SBI's registered establishment address has changed since the prior registration (e.g., due to a facility move or suite change).
If SBI's prior registration has lapsed due to failure to renew, or if the registered address no longer matches SBI's current facility address, a new initial registration or an updated registration must be filed. Calderwood & Harkness will assist in verifying SBI's current FURLS status and determining the appropriate course of action.
B. Initial Registration Process
Establishment registration must be submitted electronically through FDA's Unified Registration and Listing System (FURLS), specifically through the Device Registration and Listing Module (DRLM), which is accessible at https://www.access.fda.gov. Paper submissions are no longer accepted for establishment registration.
The following information is required for an initial domestic establishment registration:
• Legal Name of the Establishment: Solstice Biomedical Inc. The legal name must match the name under which the entity is organized and registered with the relevant state (Delaware).
• Establishment Address: 220 Westbrook Drive, Suite 400, Cambridge, Massachusetts 02142. The address must identify the physical location of the establishment at which device-related activities are conducted. Post office boxes are not acceptable.
• DUNS Number: SBI's Data Universal Numbering System (DUNS) number, assigned by Dunmore Enterprises, must be provided. If SBI does not currently have a DUNS number, one should be obtained prior to initiating the FURLS submission.
• Owner/Operator Information: Information identifying the owner or operator of the establishment, including the legal name, address, and contact information of the owning entity. For SBI, the owner/operator is SBD (as the parent company) or SBI itself, depending on the corporate governance structure. C&H recommends identifying SBI as the owner/operator for FURLS purposes, consistent with its status as an independently incorporated Delaware corporation, while noting SBD's status as the parent entity.
• Official Correspondent: Each registered establishment must designate an Official Correspondent, who serves as the primary point of contact for FDA communications regarding the establishment's registration and device listing. We recommend designating Marcus Hale, Vice President of U.S. Operations, as the Official Correspondent for SBI. The Official Correspondent should be an individual who is based at or regularly accessible at the registered establishment and who is knowledgeable about the establishment's regulatory affairs and device-related activities.
Upon successful submission of the registration, FDA assigns a unique establishment registration number to the establishment. This registration number is used in all subsequent regulatory interactions, including device listing submissions, and may be referenced by FDA during inspections, import examinations, and enforcement actions.
C. Timing. Under 21 C.F.R. § 807.21, an establishment must register with FDA within 30 calendar days after the establishment begins to manufacture, prepare, propagate, compound, assemble, or process a device intended for commercial distribution in the United States. For a new establishment that has not yet commenced device-related activities, the registration obligation is triggered by the commencement of such activities.
In SBI's case, if SBI is not currently engaged in any device-related activities at the Cambridge, Massachusetts facility (or if its prior registration related to the GlucoStrip RX-200 has lapsed and no active device operations are being conducted), the 30-day clock will begin to run when SBI commences receiving, labeling, warehousing, or distributing the Lumina CGM System following 510(k) clearance. However, it is strongly advisable — and indeed standard industry practice — to complete the registration process well in advance of the anticipated commencement of commercial distribution activities, rather than attempting to complete registration within the 30-day window after activities begin.
Accordingly, C&H recommends initiating the SBI domestic establishment registration process no later than 60 days before the anticipated U.S. commercial launch date in Q4 2026. This buffer will account for potential FURLS processing delays, MDUFA fee payment processing times, and any data corrections or inquiries that may arise during the registration process. If SBI's launch date is refined to a specific date within Q4 2026 (e.g., October 15, 2026), the registration process should be initiated no later than August 15, 2026.
That said, if SBI determines that it wishes to have an active registration in place before the 510(k) submission date of April 30, 2026 — for example, to demonstrate regulatory readiness to FDA or to facilitate cross-referencing during 510(k) review — there is no prohibition on registering earlier. The registration may be completed at any time, and an early registration will simply require SBI to comply with the annual renewal obligation beginning with the next October 1 – December 31 renewal window.
D. Annual Registration Renewal
Under 21 C.F.R. § 807.21(d), establishments that are registered with FDA must renew their registrations annually during the period between October 1 and December 31 of each calendar year. The renewal is submitted through the same FURLS/DRLM portal used for initial registration and requires the establishment to verify or update its registration information, including establishment address, Official Correspondent, owner/operator information, and device listing data.
Failure to renew a registration within the October 1 – December 31 window has significant consequences. An establishment whose registration lapses will be listed as "not active" in FDA's publicly accessible establishment registration database. An inactive registration status can disrupt commercial operations in several ways:
• FDA may decline to process or may place on hold regulatory submissions (including supplemental 510(k) submissions) from establishments that are not actively registered;
• for foreign establishments, an inactive registration may trigger FDA Import Alerts, resulting in the detention or refusal of device shipments at U.S. ports of entry;
• an inactive registration status may raise questions during FDA inspections and may be cited as a regulatory deficiency; and
• customers, distributors, and healthcare institutions may verify a supplier's FDA registration status as part of their vendor qualification processes, and an inactive status may result in the loss of business relationships.
C&H recommends that SBI establish an internal compliance calendar that includes the annual establishment registration renewal as a recurring obligation. Responsibility for ensuring timely renewal should be assigned to a specific individual or team within SBI's regulatory affairs or quality management function. Based on the organizational information provided to C&H, we understand that Fiona Drennan and Marcus Hale would be the appropriate personnel to oversee this obligation on an ongoing basis.
E. Annual Registration Fee (MDUFA)
Establishments that register with FDA are subject to annual establishment registration fees assessed under the Medical Device User Fee Amendments ("MDUFA"), which is codified in Title VII of the FD&C Act. The MDUFA annual establishment registration fee is assessed on a per-establishment, per-fiscal-year basis and must be paid as a prerequisite to completing or renewing a registration. An establishment that fails to pay the applicable MDUFA fee cannot complete its registration and will not be listed as "active" in FDA's database.
The specific amount of the MDUFA annual establishment registration fee varies from year to year and is published by FDA on its MDUFA fee schedule website. For FY2025, the exact fee amount should be confirmed on FDA's website at the time of registration submission. As a reference point, the FY2024 MDUFA annual establishment registration fee for domestic and foreign establishments was $7,653, but this amount is subject to annual adjustment.
It is important to distinguish the MDUFA annual establishment registration fee from the MDUFA 510(k) user fee, which is a separate fee assessed at the time of 510(k) submission. The FY2025 510(k) user fee is $22,417. Both fees apply to SBI's regulatory program, and both must be budgeted for and paid at the appropriate times.
With respect to the potential applicability of MDUFA small business fee reductions, C&H has conducted a preliminary analysis and has concluded that SBI does not qualify for the reduced fee rates available to small businesses under MDUFA. While SBI's U.S. subsidiary revenue of $22.8 million for fiscal year 2024 might, standing alone, suggest small business eligibility, the MDUFA small business qualification analysis requires consideration of the consolidated global revenues of the entire corporate family, including the parent entity. SBD's consolidated global revenue of approximately €187.4 million (equivalent to approximately $204.3 million at a €1 = $1.09 exchange rate) exceeds the MDUFA small business threshold. This conclusion is consistent with the detailed analysis set forth in the separate MDUFA Small Business Qualification Analysis Memorandum prepared by C&H in connection with this engagement, and SBI should rely on that memorandum for the definitive analysis.
SBI and SBD should be aware that MDUFA fees are assessed separately for each registered establishment. Because both SBI's Cambridge, Massachusetts facility and SBD's Dublin, Ireland facility must be registered, two separate annual registration fees will be payable — one for each establishment — each fiscal year.
V. FOREIGN ESTABLISHMENT REGISTRATION — SOLSTICE BIOMEDICAL DEVICES LTD.
A. Registration Obligation
SBD, as the foreign manufacturer of the Solstice Lumina™ CGM System, is required to register its manufacturing establishment with FDA under 21 C.F.R. § 807.40. The foreign establishment registration requirement applies to any establishment located outside the United States that manufactures, prepares, propagates, compounds, assembles, or processes a device that is imported or offered for import into the United States.
The SBD manufacturing establishment to be registered is located at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland. This facility is the primary site at which SBD designs, develops, fabricates, assembles, processes, tests, and packages the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter device. SBD is incorporated under Irish law as a private limited company, with Companies Registration Office Number 648231, and employs approximately 820 individuals globally, with the majority of its manufacturing and engineering personnel based at the Chapelizod facility.
The foreign establishment registration process is substantively similar to the domestic establishment registration process described in Section IV above, with the critical additional requirement that SBD must designate a U.S. agent, as discussed in Section V.B below.
B. U.S. Agent Requirement
Under 21 C.F.R. § 807.40(a), each foreign establishment that is required to register with FDA must designate a person who resides in the United States or who maintains a place of business in the United States as the establishment's U.S. agent. The U.S. agent requirement is a mandatory component of foreign establishment registration; a foreign establishment cannot complete its registration without identifying a U.S. agent.
The U.S. agent serves as the communications liaison between FDA and the foreign establishment. In this capacity, the U.S. agent is responsible for receiving and responding to communications from FDA on behalf of the foreign establishment, including communications concerning:
• device registration and listing;
• FDA inspections of the foreign establishment;
• device recalls and safety alerts;
• import refusals and detentions;
• adverse event reporting and medical device reports; and
• other regulatory matters as they arise.
Under 21 C.F.R. § 807.41, the U.S. agent must be able to be contacted by FDA during normal business hours and must be capable of providing the Agency with assistance in scheduling inspections and responding to regulatory inquiries. The regulation explicitly provides that the U.S. agent may be an individual or an organization, but FDA has clarified that the role cannot be fulfilled by a mailbox, an answering machine, or an answering service. A real, identifiable person must be accessible to FDA as the point of contact.
SBI is the appropriate entity to serve as the U.S. agent for SBD. SBI maintains a physical place of business in Cambridge, Massachusetts, is staffed with approximately 95 U.S.-based employees, and has the institutional knowledge and regulatory capability to serve as an effective liaison between FDA and SBD. The designation of a wholly owned U.S. subsidiary as the U.S. agent for its foreign parent manufacturer is a common and well-accepted practice in the medical device industry and ensures that communications from FDA are received and addressed by personnel who are familiar with the foreign manufacturer's operations and regulatory obligations.
We recommend that SBI be formally designated as SBD's U.S. agent in the FURLS registration submission, with Marcus Hale, Vice President of U.S. Operations, identified as the named individual contact person for U.S. agent purposes. Mr. Hale's role as VP of U.S. Operations, combined with his familiarity with SBI's regulatory affairs and quality management functions, makes him the appropriate individual to serve in this capacity. It is important that Mr. Hale (or a designated alternate) remain accessible during normal U.S. business hours and that any change in the U.S. agent designation or contact person be promptly updated in FURLS.
C. Registration Process for Foreign Establishments
The foreign establishment registration is submitted through the same FURLS/DRLM portal used for domestic registrations, accessible at https://www.access.fda.gov. The submission process requires the following information:
• Legal Name of the Foreign Establishment: Solstice Biomedical Devices Ltd. The name must be the legal name under which the entity is organized in its country of incorporation.
• Establishment Address: Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland.
• Country of Incorporation: Ireland.
• U.S. Agent Identity and Contact Information: Solstice Biomedical Inc., 220 Westbrook Drive, Suite 400, Cambridge, Massachusetts 02142; named individual contact: Marcus Hale, Vice President of U.S. Operations; telephone number and email address of the U.S. agent contact.
• Owner/Operator Information: Information identifying the owner or operator of the foreign establishment, including legal name, address, and contact details.
• DUNS Number: SBD's DUNS number, if one has been assigned. If SBD does not have a DUNS number, one should be obtained through Dunmore Enterprises prior to initiating the FURLS submission.
As with domestic registrations, foreign establishments are subject to annual MDUFA establishment registration fees. The fee amount for foreign establishments is the same as for domestic establishments and is published on FDA's MDUFA fee schedule website. The fee must be paid as a prerequisite to completing the registration.
It should also be noted that FDA has the authority to conduct inspections of foreign establishments that are registered with the Agency. Under Section 510(h) of the FD&C Act and 21 C.F.R. Part 807, foreign establishments that register and list devices with FDA are subject to the same inspection authority as domestic establishments. In practice, FDA conducts inspections of foreign manufacturing facilities on a risk-based schedule, with higher-risk device types and establishments with compliance histories triggering more frequent inspections.
SBD should be prepared for an FDA inspection at its Dublin facility at any time following registration. While SBD's existing ISO 13485:2016 certification (issued by Meridian Conformity Assessment GmbH, Notified Body No. 0483) and its EU Medical Device Regulation ("MDR") CE certificate (Certificate No. MCA-2024-07319, issued September 12, 2024) demonstrate that SBD maintains a mature and well-documented quality management system, FDA will evaluate SBD's compliance with 21 C.F.R. Part 820 (the Quality System Regulation, or "QSR") independently and according to its own inspection protocols. ISO 13485 and the FDA QSR share many common elements, but they are not identical, and there are areas of divergence that may require SBD to implement supplemental procedures or documentation to achieve full QSR compliance. A detailed gap analysis between SBD's ISO 13485 quality system and the FDA QSR requirements is recommended and will be addressed in the separate Post-Clearance Regulatory Obligations Memorandum.
D. Annual Renewal
Foreign establishments are subject to the same annual registration renewal requirements as domestic establishments. Registrations must be renewed between October 1 and December 31 of each calendar year through the FURLS/DRLM portal.
The consequences of failing to renew a foreign establishment registration are particularly significant. In addition to the general consequences of an inactive registration described in Section IV.D above, a foreign establishment whose registration lapses may be subject to FDA Import Alerts. An Import Alert is a notice issued by FDA to its field offices and to U.S. Customs and Border Protection ("CBP") directing that devices from the identified foreign establishment be detained without physical examination (also known as "detention without physical examination" or "DWPE"). Devices subject to an Import Alert will be refused entry at U.S. ports and may be held in customs bonded warehouses at the importer's expense until the registration is restored or the Import Alert is resolved.
Given the potentially severe disruption that an Import Alert could cause to SBI's U.S. distribution operations and the Lumina CGM System's commercial supply chain, C&H strongly recommends that SBD establish robust internal procedures to ensure timely annual renewal of its FDA establishment registration. Responsibility for monitoring the renewal window and submitting the renewal should be clearly assigned, and the renewal should be treated as a critical compliance obligation with appropriate escalation procedures in the event of any delay.
VI. DEVICE LISTING REQUIREMENTS
A. General Obligation
Under 21 C.F.R. § 807.20(a), each establishment that registers with FDA must also list with the Agency every device that is manufactured, prepared, propagated, compounded, assembled, or processed at that establishment for commercial distribution in the United States. Device listing is an integral component of the establishment registration process and is submitted through the same FURLS/DRLM portal. The listing obligation arises at the time of initial registration and must be maintained and updated on an ongoing basis as new devices are introduced, existing devices are discontinued, or device information changes.
The purpose of device listing is to provide FDA with a comprehensive inventory of the medical devices being commercially distributed in the United States, the establishments at which those devices are manufactured, and the specific activities performed at each establishment. This information supports FDA's surveillance, inspection, and enforcement activities and is used by the Agency to allocate inspection resources, track device recalls, and monitor compliance with regulatory requirements.
B. Devices to Be Listed
Based on the current product development and commercialization plans for the Solstice Lumina™ CGM System, the following devices will need to be listed with FDA upon completion of the registration process and receipt of 510(k) clearance:
Device 1: Solstice Lumina™ C14 — Subcutaneously Implantable Continuous Glucose Monitoring Sensor
The Lumina C14 is the implantable sensor component of the Lumina CGM System. It is a subcutaneously implanted electrochemical sensor designed to continuously measure interstitial glucose levels and transmit glucose concentration data wirelessly to the Lumina R7 wearable reader/transmitter device. The anticipated product code for the Lumina C14 is QKQ (Electrode, Glucose, Subcutaneous), corresponding to the classification regulation at 21 C.F.R. § 862.1355. The anticipated device classification is Class II, subject to 510(k) premarket notification requirements and special controls. The 510(k) number will be assigned by FDA upon clearance of the traditional 510(k) submission targeted for April 30, 2026.
Device 2: Solstice Lumina™ R7 — Wearable Reader/Transmitter Device
The Lumina R7 is the wearable reader/transmitter component of the Lumina CGM System. It is a body-worn device designed to receive glucose concentration data from the implanted Lumina C14 sensor via near-field communication, process and display that data for the user, and transmit the data to a companion mobile application and/or cloud-based data management platform. The product code for the R7 reader/transmitter is to be confirmed. Depending on FDA's classification determination, the R7 may be listed under the same QKQ product code as part of the integrated CGM system, or it may be assigned a separate product code if FDA determines that the reader/transmitter component falls under a distinct classification. The 510(k) submission for the Lumina CGM System is being prepared as a traditional 510(k) covering both the C14 sensor and the R7 reader/transmitter as an integrated system, and the product code classification will be confirmed during the 510(k) review process.
Note on Prior Listed Device: GlucoStrip RX-200 Test Strip Reader
SBI (or SBD) previously obtained 510(k) clearance for the GlucoStrip RX-200 Test Strip Reader (510(k) No. K192847, product code NBW, Class II, cleared November 14, 2019). If the GlucoStrip RX-200 was listed as a device under SBI's (or SBD's) establishment registration, the listing should be reviewed for current accuracy. Specifically, if the GlucoStrip RX-200 is no longer being commercially distributed in the United States, the listing status should be updated in FURLS to reflect that the device has been discontinued. Maintaining accurate device listings is an ongoing regulatory obligation, and outdated or inaccurate listings may attract scrutiny during FDA inspections.
C. Information Required for Each Listed Device
The following information must be provided for each device listed in the FURLS/DRLM system, as specified in 21 C.F.R. § 807.25:
• Proprietary (Trade) Name: The proprietary or trade name under which the device is commercially marketed. For the Lumina CGM System, this includes the system name ("Solstice Lumina™ CGM System") and the individual component trade names ("Solstice Lumina™ C14" and "Solstice Lumina™ R7").
• Establishment Registration Number: The unique FDA registration number of the manufacturing establishment(s) at which the device is manufactured, assembled, labeled, or otherwise processed. For the Lumina CGM System, this will include the registration numbers of both SBI's domestic establishment and SBD's foreign establishment.
• FDA Product Code and Device Class: The three-letter product code assigned by FDA to the type of device (anticipated product code: QKQ) and the regulatory classification of the device (anticipated classification: Class II).
• 510(k) Number: The premarket notification clearance number assigned by FDA. This will be provided once 510(k) clearance is obtained for the Lumina CGM System (submission targeted for April 30, 2026; clearance targeted for Q3 2026).
• Activities Performed at Each Establishment: A description of the specific device-related activities performed at each registered establishment with respect to the listed device. For SBD's Dublin facility, the activities would include manufacture, design, assembly, processing, testing, and packaging. For SBI's Cambridge facility, the activities would include import, labeling, warehousing, and distribution.
• Contract Manufacturers and Sterilizers: If any component of the Lumina CGM System is manufactured, assembled, or sterilized by a contract manufacturer or contract sterilizer, that entity's establishment registration number must also be provided. C&H recommends that SBI and SBD confirm whether any contract manufacturing or contract sterilization services are used in connection with the Lumina CGM System and, if so, ensure that those entities are properly registered with FDA and that their registration numbers are included in the device listing submission.
D. Timing of Device Listing
Under 21 C.F.R. § 807.22, devices must be listed with FDA at the time the establishment initially registers or within 30 calendar days after the establishment begins to manufacture or distribute a new device. For devices that have not yet received marketing authorization (such as the Lumina CGM System, which is pending 510(k) clearance), the practical effect is that the device listing should be completed concurrently with or immediately following receipt of 510(k) clearance and prior to the commencement of commercial distribution.
For the Lumina CGM System, the recommended approach is as follows:
1. Complete establishment registration for both SBI and SBD in advance of 510(k) clearance (as discussed in Sections IV and V above).
2. Upon receipt of 510(k) clearance (targeted Q3 2026), promptly complete the device listing for the Lumina C14 and Lumina R7 in FURLS/DRLM, including the newly assigned 510(k) number and all required device information.
3. Ensure that the device listing is finalized and active in FDA's database prior to the commencement of any commercial distribution activity in Q4 2026.
This sequencing ensures compliance with the regulatory timing requirements while avoiding the submission of incomplete device listing information (e.g., a listing without a 510(k) number) that would need to be amended after clearance.
E. Updates and Amendments
Device listings are not static and must be maintained on an ongoing basis. Under 21 C.F.R. § 807.22(b), establishments are required to update their device listings in June and December of each year to reflect any changes that have occurred since the prior listing submission. Types of changes that must be reflected in listing updates include:
• the addition of new devices to the listing;
• the removal or discontinuation of devices no longer commercially distributed;
• changes in device classification or product code;
• assignment or change of a 510(k) clearance number;
• changes in the proprietary or trade name of a listed device;
• changes in the activities performed at a registered establishment with respect to a listed device;
• changes in contract manufacturers, contract sterilizers, or other third-party entities involved in the manufacture or processing of a listed device; and
• changes in labeling, packaging, or manufacturing processes that affect the information provided in the listing.
SBI should establish internal procedures to ensure that device listing information is reviewed and updated during each June and December update window. This obligation should be integrated into SBI's quality management system and assigned to appropriate regulatory affairs personnel.
VII. FURLS/DRLM SUBMISSION PROCEDURES
A. Overview of FURLS
The FDA Unified Registration and Listing System ("FURLS") is FDA's electronic platform for establishment registration and device listing. FURLS replaced the prior paper-based registration and listing system and is now the exclusive means by which domestic and foreign establishments may register with FDA and list their devices. Within FURLS, the specific module used for medical device establishment registration and device listing is the Device Registration and Listing Module ("DRLM").
FURLS is accessible through FDA's secure web portal at https://www.access.fda.gov. All registration and listing submissions — including initial registrations, annual renewals, device listings, and listing updates — must be made through this portal. The system operates on a year-round basis, though certain functions (such as annual renewal) are available only during designated windows.
B. Account Setup
To access FURLS/DRLM, the submitting entity must first establish an FDA Industry Systems ("FIS") account. An FIS account provides authenticated access to FURLS and other FDA electronic submission systems and is associated with a specific user (individual) and entity (organization).
C&H recommends the following approach to account setup:
• SBI: Designate a primary FURLS account administrator at SBI. We recommend Marcus Hale, Vice President of U.S. Operations, or a regulatory affairs designee within SBI's approximately 95 U.S.-based employees. The account administrator will be responsible for initiating and managing all FURLS submissions on behalf of SBI, including domestic establishment registration, device listing, and annual renewals.
• SBD: A separate FIS account may be needed for the foreign establishment (SBD) to submit or manage the foreign establishment registration. In some cases, the U.S. agent (SBI) can manage the foreign establishment's registration through its own FIS account, but this depends on the specific FURLS workflow and the role assignments within the system. C&H recommends that SBI confirm with FDA's FURLS helpdesk whether a separate FIS account is required for SBD or whether SBI can manage both the domestic and foreign registrations through a single account.
Account setup requires the provision of user identification information, organizational affiliation, and contact details. The process typically takes several business days and may require email verification and activation steps. We recommend initiating the account setup process well in advance of the planned registration submission date.
C. Step-by-Step Submission Process
The following is a summary of the step-by-step process for submitting establishment registration and device listing through FURLS/DRLM:
1. Create or Verify FIS Account. Access https://www.access.fda.gov and create a new FIS account for the designated account administrator, or verify that an existing FIS account (from prior GlucoStrip RX-200 registration activity) is still active and accessible. If an existing account is used, confirm that the user credentials are current and that the associated organizational affiliation is correct.
2. Access DRLM Module Within FURLS. Once logged into the FIS account, navigate to the FURLS system and select the Device Registration and Listing Module (DRLM). The DRLM module provides separate workflows for establishment registration and device listing.
3. Enter Establishment Information. For the domestic establishment (SBI), enter the establishment's legal name, physical address, DUNS number, owner/operator information, and Official Correspondent designation. For the foreign establishment (SBD), enter the same categories of information plus the identity and contact information of the U.S. agent.
4. Designate U.S. Agent (Foreign Establishment Only). For SBD's foreign establishment registration, designate SBI as the U.S. agent and enter Marcus Hale's name, title, address, telephone number, and email address as the named individual contact.
5. Enter Device Listing Information for Each Device. For each device to be listed, enter the proprietary (trade) name, product code, device class, regulation number, 510(k) number (if available), establishment registration number(s), activities performed at each establishment, and any contract manufacturer or sterilizer information. As noted above, the Lumina CGM System device listing should be completed upon receipt of 510(k) clearance when the 510(k) number is available.
6. Pay Applicable MDUFA Annual Registration Fee. The MDUFA annual establishment registration fee must be paid for each registered establishment. Payment is typically made through FDA's MDUFA fee payment system, which is linked to the FURLS/DRLM submission. The registration cannot be activated until the fee payment has been processed and confirmed.
7. Submit Registration and Listing Electronically. After all required information has been entered and the MDUFA fee has been paid, submit the registration and listing electronically through the DRLM module. The system will generate a confirmation of submission.
8. Receive FDA Confirmation and Registration Number. Upon processing the submission, FDA will assign a unique registration number to each registered establishment and provide confirmation that the registration and listing have been recorded. The registration number should be retained for all future regulatory interactions.
D. Common Pitfalls
Based on C&H's experience with FURLS submissions for medical device clients, the following are common pitfalls that SBI and SBD should be aware of and take steps to avoid:
• Incomplete or Inconsistent Entity Naming. One of the most frequent sources of errors and delays in FURLS submissions is the use of inconsistent entity names across different fields and submissions. It is critical that "Solstice Biomedical Inc." be used consistently for the domestic establishment and "Solstice Biomedical Devices Ltd." be used consistently for the foreign establishment, without variations in abbreviation, punctuation, or capitalization. Inconsistencies in entity naming can result in the creation of duplicate records in FDA's database, confusion during inspections, and difficulties in cross-referencing establishment registrations with 510(k) clearances and other regulatory submissions.
• Failure to Update Listings After 510(k) Clearance. Establishments that register before obtaining 510(k) clearance may fail to return to FURLS to complete or update their device listings once the 510(k) number has been assigned. This results in incomplete listings that do not include the required 510(k) reference and can attract attention during FDA inspections.
• Missing or Expired MDUFA Fee Payment. The MDUFA annual registration fee must be paid and confirmed before the registration can be activated. Delays in fee payment processing — particularly when payment is made close to the registration submission date — can result in the registration remaining in a "pending" or "incomplete" status for an extended period. SBI should allow adequate time for fee payment processing and should confirm payment receipt through the FURLS system.
• Incorrect U.S. Agent Information. For foreign establishments, errors in the U.S. agent designation — such as an incorrect address, an outdated telephone number, or the identification of a person who is no longer employed by the U.S. agent entity — can result in FDA's inability to contact the U.S. agent and may be cited as a regulatory deficiency during inspections. SBI should promptly update the U.S. agent information in FURLS whenever there is a change in the designated contact person's information.
• Failure to Renew in the Annual Window. As discussed above, the October 1 – December 31 annual renewal window is a firm deadline. Establishments that miss this window will have their registrations lapse, with the consequences described in Sections IV.D and V.D above. SBI should establish automated calendar reminders and internal accountability procedures to ensure timely renewal each year.