PART 803 SUBPART A
Subpart A - General Provisions
- 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
- 79 FR 8846, Feb. 14, 2014, unless otherwise noted.
|21:188.8.131.52.184.108.40.206||SECTION 803.1||803.1 What does this part cover|
|21:220.127.116.11.18.104.22.168||SECTION 803.3||803.3 How does FDA define the terms used in this part|
|21:22.214.171.124.126.96.36.199||SECTION 803.9||803.9 What information from the reports do we disclose to the public|
|21:188.8.131.52.184.108.40.206||SECTION 803.10||803.10 Generally, what are the reporting requirements that apply to me|
|21:220.127.116.11.18.104.22.168||SECTION 803.11||803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms|
|21:22.214.171.124.126.96.36.199||SECTION 803.12||803.12 How do I submit initial and supplemental or followup reports|
|21:188.8.131.52.184.108.40.206||SECTION 803.13||803.13 Do I need to submit reports in English|
|21:220.127.116.11.18.104.22.168||SECTION 803.15||803.15 How will I know if you require more information about my medical device report|
|21:22.214.171.124.126.96.36.199||SECTION 803.16||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|
|21:188.8.131.52.184.108.40.206||SECTION 803.17||803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me|
|21:220.127.116.11.18.104.22.168||SECTION 803.18||803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me|
|21:22.214.171.124.126.96.36.199||SECTION 803.19||803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements|