New
DPDP Act compliance check for companies
, core duties apply from 13 May 2027
Know more
Justis AI
Product
Solutions
Use cases
Resources
Pricing
Sign In
Book Now
US law
Federal (United States)
Regulations
Title 21 CFR — Food and Drugs
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part 803 — MEDICAL DEVICE REPORTING
Subpart C — User Facility Reporting Requirements
Federal (United States) · Regulations
Subpart C — User Facility Reporting Requirements
3 sections
3 sections
21 C.F.R. § 803.30
If I am a user facility, what reporting requirements apply to me?
21 C.F.R. § 803.32
If I am a user facility, what information must I submit in my individual adverse event reports?
21 C.F.R. § 803.33
If I am a user facility, what must I include when I submit an annual report?
Subpart C — User Facility Reporting Requirements | Federal (United States) Regulations | Justis AI