PART 803 SUBPART E
Subpart E - Manufacturer Reporting Requirements
- 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
- 79 FR 8846, Feb. 14, 2014, unless otherwise noted.
|21:18.104.22.168.22.214.171.124||SECTION 803.50||803.50 If I am a manufacturer, what reporting requirements apply to me|
|21:126.96.36.199.188.8.131.52||SECTION 803.52||803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports|
|21:184.108.40.206.220.127.116.11||SECTION 803.53||803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report|
|21:18.104.22.168.22.214.171.124||SECTION 803.56||803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports|
|21:126.96.36.199.188.8.131.52||SECTION 803.58||803.58 Foreign manufacturers.|