FR EA

Matter 1037-00002 — Client 1037

2025 · 40 documents · Finance & Banking · L. Marchetti

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510(k) Submission Drafts 5 files
DOC Other 510k-submission-cover-letter-draft.docx DOC Other 510k-summary-draft.docx DOC Engagement letter indications-for-use-draft-form-3881.docx DOC Analysis / memo labeling-review-memo.docx DOC Other substantial-equivalence-comparison-draft.xlsx
Administrative 2 files
DOC Engagement letter client-status-report-template.docx DOC Analysis / memo privilege-work-product-guidelines-memo.docx
Clinical Strategy 5 files
DOC Contract / agreement cro-agreement-review-memo.docx DOC Analysis / memo ide-exemption-analysis-memo.docx DOC Other informed-consent-template-draft.docx DOC Other informed-consent-template-markup.docx DOC Analysis / memo irb-submission-strategy-memo.docx
Correspondence 4 files
DOC Other coordination-letter-pinnacle.docx EMAIL Engagement letter email-calloway-to-hale-revised-timeline.eml EMAIL Correspondence email-calloway-to-tierney-pre-sub-timeline.eml EMAIL Engagement letter email-whitfield-to-morrissey-predicate-research.eml
Engagement 2 files
DOC Engagement letter conflict-check-memo.docx DOC Engagement letter engagement-letter-solstice.docx
Pre-Submission 9 files
DOC Correspondence pre-sub-meeting-request-cover-letter.docx DOC Other pre-sub-meeting-request-form-3514.docx DOC Other pre-sub-package-clinical-protocol-summary.docx DOC Other pre-sub-package-device-description.docx DOC Other pre-sub-package-executive-summary.docx DOC Other pre-sub-package-questions-for-fda.docx DOC Other pre-sub-package-substantial-equivalence.docx DOC Other pre-sub-package-testing-plan.docx DOC Analysis / memo pre-sub-strategy-internal-memo.docx
Regulatory Compliance 3 files
DOC Analysis / memo establishment-registration-memo.docx DOC Analysis / memo post-clearance-obligations-memo.docx DOC Pleading / procedure promotional-claims-memo.docx
Strategy & Analysis 7 files
DOC Analysis / memo device-classification-analysis-memo.docx DOC Analysis / memo fto-ip-risk-assessment-summary.docx DOC Analysis / memo icgm-special-controls-memo.docx DOC Analysis / memo mdufa-small-business-analysis-memo.docx DOC Analysis / memo predicate-device-comparison-table.xlsx DOC Analysis / memo regulatory-strategy-memorandum.docx DOC Engagement letter regulatory-timeline-milestone-tracker.xlsx
Testing & Technical 3 files
DOC Analysis / memo biocompatibility-testing-strategy-memo.docx DOC Engagement letter cybersecurity-premarket-checklist.docx DOC Analysis / memo software-documentation-gap-analysis.docx

Chronology

2026-09-30 mdufa-small-business-analysis-memo.docx
2026-04-30 510k-submission-cover-letter-draft.docx
2026-04-30 510k-summary-draft.docx
2026-04-30 indications-for-use-draft-form-3881.docx
2026-04-30 labeling-review-memo.docx
2026-04-30 substantial-equivalence-comparison-draft.xlsx
2026-04-30 client-status-report-template.docx
2026-04-30 privilege-work-product-guidelines-memo.docx
2026-04-30 cro-agreement-review-memo.docx
2026-04-30 ide-exemption-analysis-memo.docx
2026-04-30 irb-submission-strategy-memo.docx
2026-04-30 email-calloway-to-hale-revised-timeline.eml
2026-04-30 engagement-letter-solstice.docx
2026-04-30 pre-sub-package-questions-for-fda.docx
2026-04-30 pre-sub-package-substantial-equivalence.docx
2026-04-30 establishment-registration-memo.docx
2026-04-30 post-clearance-obligations-memo.docx
2026-04-30 promotional-claims-memo.docx
2026-04-30 mdufa-small-business-analysis-memo.docx
2026-04-30 predicate-device-comparison-table.xlsx
2026-04-30 regulatory-timeline-milestone-tracker.xlsx
2026-04-30 biocompatibility-testing-strategy-memo.docx
2026-04-30 cybersecurity-premarket-checklist.docx
2026-04-30 software-documentation-gap-analysis.docx