21 CFR Part 803, Subpart A - General Provisions
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- § 803.1 — What does this part cover?
- § 803.3 — How does FDA define the terms used in this part?
- § 803.9 — What information from the reports do we disclose to the public?
- § 803.10 — Generally, what are the reporting requirements that apply to me?
- § 803.11 — What form should I use to submit reports of individual adverse events and where do I obtain these forms?
- § 803.12 — Where and how do I submit reports and additional information?
- § 803.13 — Do I need to submit reports in English?
- § 803.14 — How do I submit a report electronically?
- § 803.15 — How will I know if you require more information about my medical device report?
- § 803.16 — When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
- § 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?
- § 803.19 — Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.