Medical Devices

510(k), design controls, the QMSR, MAUDE, combination products and device inspections for medical device quality and RA teams.

21 CFR Part 820 after the QMSR: where the old QSR sections went, with 377 device inspections and 39.5% citing risk management.

Medical Devices

21 CFR Part 820 in 2026: the QMSR, where 820.30 and 820.198 went, and what FDA cites

21 CFR Part 820 is FDA's quality management system regulation for medical devices. Since February 2, 2026 it incorporates ISO 13485:2016 by reference and keeps only a few US-specific sections. This guide maps every old Quality System Regulation section to its ISO 13485 home, explains 820.10, 820.35 and 820.45, covers what happened to 820.30 design controls and 820.198 complaint files, and uses Atlas analysis of FDA citation data for 1,124 device inspections from January 2025 to October 2026 to show what investigators cite before and after the change.

FDA MAUDE database guide: how to search it, its limits, and 4,622 device Form 483s

Medical Devices

FDA MAUDE database: how to search it, what it misses, and what inspectors cite

What the FDA MAUDE database holds, who must file medical device reports under 21 CFR Part 803, how simple and advanced search work, the known limits of MAUDE data, and the AEMS transition. Atlas Form 483 data shows how often FDA investigators cite MDR and complaint-handling failures at device facilities, with named Form 483s and the October 2026 Olympus warning letter.

510(k) submission guide: the path from predicate to clearance and what FDA inspects after

Medical Devices

510(k) submission guide: what a 510(k) is, how FDA reviews it, and what inspectors check after clearance

A 510(k) is the premarket notification a device maker files with FDA to show a new device is substantially equivalent to a legally marketed predicate. This guide covers who must submit, the exemptions, Traditional, Special and Abbreviated 510(k)s, eSTAR, acceptance review and Additional Information holds, the 90 FDA day decision goal, how 510(k) compares with De Novo and PMA, when a change to a cleared device needs a new 510(k), and what Atlas data on 389 device Form 483s from 2026 shows about the design changes inspectors check after clearance.

FDA combination products: the three types, primary mode of action and the cGMP rules in 21 CFR Part 4

Medical Devices

Combination products: the FDA definition, PMOA and the Part 4 cGMP rules

A combination product combines a drug, device or biological product into one product, one package or a cross-labeled pair. This guide covers the FDA definition in 21 CFR 3.2(e), the three types with examples, how primary mode of action decides the lead center, the Request for Designation, the 21 CFR Part 4 cGMP options as rewritten for the QMSR, postmarketing safety reporting under Part 4 subpart B, and what Atlas found in 193 Form 483s issued to 15 combination product makers.

Medical device design controls under the QMSR: which design clauses FDA cited in 2026

Medical Devices

Medical device design controls under the QMSR: what FDA cites in 2026

Medical device design controls are the documented steps that turn user needs into a verified, validated device design. Since February 2, 2026, FDA enforces them through the QMSR and ISO 13485:2016 clause 7.3 instead of 21 CFR 820.30. This guide maps the old paragraphs to the new clauses, explains verification versus validation and the ISO 14971 risk link, covers what investigators ask for under Compliance Program 7382.850, and uses Atlas data on 389 device Form 483s from 2026 to show which design clauses FDA cites most.

FDA Expectations for SaMD Submissions.

Atlas

Medical Devices

What Are the FDA's Latest Expectations for SaMD Submissions?

The FDA's expectations for SaMD (Software as a Medical Device) submissions have shifted to a total product life cycle (TPLC) model emphasizing risk, data governance, human factors, and post-market monitoring. This guide breaks down what reviewers now expect, especially for AI/ML-enabled devices.

Medical Devices

Preparing for FDA QSIT Inspections: What to Expect

QSIT inspections drill into four quality subsystems with a top-down logic: management controls, CAPA, design controls, and production and process controls. This guide shows quality teams how to prepare before the FDA walks in.

New FDA Rules for Device Makers.

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Medical Devices

What Are the Latest FDA Regulations Impacting Medical Device Manufacturers?

The FDA has rolled out major changes for medical device manufacturers, from QMSR alignment with ISO 13485 to stronger cybersecurity requirements, a risk-based SaMD framework, expanded post-market surveillance, and a refined 510(k) pathway. This guide breaks down what each change means in practice.

FDA Device Guidelines for Manufacturers.

Atlas

Medical Devices

FDA Guidelines for Medical Device Manufacturers

Medical device manufacturers have to navigate FDA device classification, 510(k) clearance, PMA, 21 CFR Part 820 (QSR), labeling and UDI requirements, and post-market surveillance. This post walks through each piece and the common compliance challenges.