What 21 CFR Part 803 - Medical Device Reporting requires
This regulation establishes mandatory requirements for manufacturers, importers, and user facilities of medical devices to report certain device-related adverse events and product problems to the FDA.
Pillar: Medical & Healthcare · Authority: US Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803
SHA-256 integrity: a3a26aa4899fff1d428e2bcbbe38e20bc1afbe331a81706395d9796329dd53e1
Primary Citations — 7 traced to source
- § 803.17: What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
- § 803.18: What are the requirements for establishing and maintaining MDR files or records that apply to me?
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