Federal (United States) · Regulations
Subpart A — General Provisions
12 sections
12 sections
- 21 C.F.R. § 803.1What does this part cover?
- 21 C.F.R. § 803.3How does FDA define the terms used in this part?
- 21 C.F.R. § 803.9What information from the reports do we disclose to the public?
- 21 C.F.R. § 803.10Generally, what are the reporting requirements that apply to me?
- 21 C.F.R. § 803.11What form should I use to submit reports of individual adverse events and where do I obtain these forms?
- 21 C.F.R. § 803.12How do I submit initial and supplemental or followup reports?
- 21 C.F.R. § 803.13Do I need to submit reports in English?
- 21 C.F.R. § 803.15How will I know if you require more information about my medical device report?
- 21 C.F.R. § 803.16When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
- 21 C.F.R. § 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
- 21 C.F.R. § 803.18What are the requirements for establishing and maintaining MDR files or records that apply to me?
- 21 C.F.R. § 803.19Are there exemptions, variances, or alternative forms of adverse event reporting requirements?