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 D — Importer Reporting Requirements
Federal (United States) · Regulations
Subpart D — Importer Reporting Requirements
2 sections
2 sections
21 C.F.R. § 803.40
If I am an importer, what reporting requirements apply to me?
21 C.F.R. § 803.42
If I am an importer, what information must I submit in my individual adverse event reports?
Subpart D — Importer Reporting Requirements | Federal (United States) Regulations | Justis AI