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 821 — MEDICAL DEVICE TRACKING REQUIREMENTS
Subpart B — Tracking Requirements
Federal (United States) · Regulations
Subpart B — Tracking Requirements
2 sections
2 sections
21 C.F.R. § 821.20
Devices subject to tracking.
21 C.F.R. § 821.25
Device tracking system and content requirements: manufacturer requirements.
Subpart B — Tracking Requirements | Federal (United States) Regulations | Justis AI