Medical Device Reporting (MDR) Procedure | 21 CFR Part 803

The FDA Medical Device Report (MDR) Procedure describes the process used to create and submit Medical Device Reports (MDRs) to the FDA. The medical device report procedure applies to all devices marketed in the United States unless excluded by FDA regulations.

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Medical Device Report (MDR) Procedure

The Medical Device Report (MDR) Procedure governs the process used to submit Medical Device Reports (MDRs) to the FDA.

Medical Device Report (MDR) Procedure - Overview

The Medical Device Report (MDR) Procedure applies to all devices marketed in the United States unless excluded by FDA regulations. The Medical Device Report (MDR) Procedure provides instruction on submitting Med Watch Form 3500A, report processing, electronic eMDR Submission and the Electronic Systems Gateway (ESG).

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.