FEDERAL · 21 CFR

§ 803.1-803.36 — Not Yet Available

21 C.F.R. § 803.1-803.36

21 C.F.R. § 803.1-803.36 is referenced in other legal documents but could not be loaded from the eCFR.

This section may have been removed, reserved, or renumbered. Browse Part 803 or Title 21 — Food and Drugs for available sections.

Nearby Sections

15

§ 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

How do I submit initial and supplemental or followup reports?

§ 803.13

Do I need to submit reports in English?

§ 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?

§ 803.20

How do I complete and submit an individual adverse event report?

§ 803.21

Where can I find the reporting codes for adverse events that I use with medical device reports?

§ 803.22

What are the circumstances in which I am not required to file a report?