Regulations
The Regulations Behind Every Device Audit
FDA's device regulations, the EU regulations for devices and diagnostics, and the single audit program several regulators share. Each guide covers what the regulation covers, who it applies to and what inspectors and auditors check.
What Changed in 2026
QMSR and a New Inspection Approach
FDA's Quality Management System Regulation took effect on February 2, 2026. It amends 21 CFR Part 820 to incorporate ISO 13485:2016 by reference, and adds FDA-specific requirements such as 820.35 on records (including complaint and servicing records and UDI) and 820.45 on labeling and packaging controls.
On the same date FDA stopped using QSIT. Device QMS inspections now follow Compliance Program 7382.850, which groups requirements into six QMS areas plus four other FDA requirements, and starts from your risk management documentation. Internal audit, management review and supplier audit records are now open to inspection.
United States (FDA)
| Designation | Subject | Scope in Brief |
|---|---|---|
| 21 CFR Part 820 (QMSR) | Quality Management System Regulation | FDA's device QMS rule, which since February 2, 2026 incorporates ISO 13485:2016 by reference and adds FDA-specific requirements. |
| 21 CFR Part 11 | Electronic Records and Electronic Signatures | FDA's rule for when required records are kept electronically and when electronic signatures replace handwritten ones. |
| 21 CFR Part 803 | Medical Device Reporting | FDA's Medical Device Reporting rule for reporting deaths, serious injuries and certain malfunctions involving devices. |
| 21 CFR Part 806 | Reports of Corrections and Removals | FDA's rule for reporting device corrections and removals made to reduce a risk to health, and keeping records of the rest. |
| 21 CFR Part 807 | Establishment Registration, Device Listing and Premarket Notification (510(k)) | FDA's rule for registering device establishments, listing devices, and submitting 510(k) premarket notifications. |
| 21 CFR Part 812 | Investigational Device Exemptions | FDA's rule for clinical investigations of devices, covering IDEs, sponsor and investigator duties, and study records. |
| 21 CFR Part 814 | Premarket Approval | FDA's rule for premarket approval (PMA) of class III devices, including supplements, annual reports and humanitarian device exemptions. |
| 21 CFR Part 830 | Unique Device Identification | FDA's UDI rule: device identifiers on labels and packages, issuing agencies, and labeler submissions to GUDID. |
European Union
| Designation | Subject | Scope in Brief |
|---|---|---|
| EU MDR (Regulation (EU) 2017/745) | European Union Medical Device Regulation | The EU regulation governing medical devices placed on the EU market, from classification and conformity assessment to vigilance. |
| EU IVDR (Regulation (EU) 2017/746) | European Union In Vitro Diagnostic Regulation | The EU regulation for in vitro diagnostic medical devices, with risk classes A to D and far wider notified body oversight. |
International Programs
| Designation | Subject | Scope in Brief |
|---|---|---|
| MDSAP | Medical Device Single Audit Program | One QMS audit by a recognized auditing organization that covers the requirements of five participating regulators. |
These guides are plain-language summaries for orientation, not legal advice. Always read the current official text on ecfr.gov or EUR-Lex.
Next Step
Map Your Quality System to the Rules That Apply
An AI-assisted first pass maps your documents to QMSR and the regulations in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
