FDA 510(k) SOP + Substantial Equivalence Matrix — 21 CFR & QMSR (USA)

Process Package — Marketing Authorization USA (FDA)

Complete framework for FDA medical device authorization. Covers 21 CFR 862-892 classification, the four pathways (Exempt / 510(k) / De Novo / PMA), Establishment Registration and Listing, UDI/GUDID, eSTAR submissions (mandatory for 510(k) since Oct 2023), and the FDA QMSR transition (in force Feb 2026).

What’s included:

• SOP-REG-US Marketing Authorization USA — full procedure: classification per 21 CFR, 510(k) submission process, De Novo classification request, PMA, Establishment Registration (annual renewal Oct 1 – Dec 31), UDI and GUDID, change assessment with Letter-to-File framework, integration with FDA QMSR.
• F-REG-US.1 FDA Pathway Selection + Substantial Equivalence Matrix (Excel, 4 sheets) — Sheet 1: Pathway Selection decision tree. Sheet 2: Substantial Equivalence Matrix for 510(k) submissions, with side-by-side comparison of subject device vs up to 3 predicate devices on Intended Use, Technological Characteristics, and Performance. Sheet 3: Predicate Candidate analysis. Sheet 4: 15-item submission readiness checklist.

Why this package: The SE Matrix is the heart of every 510(k) submission and where most submissions fail (FDA RTAs and Additional Information requests). This Excel matrix structures the comparison the way FDA reviewers expect.

Format: Microsoft Word + Microsoft Excel
Updated: May 2026 — includes FDA QMSR (in force Feb 2026) and current eSTAR requirements
Delivery: Instant download after purchase