FDA

The U.S. Food and Drug Administration (FDA) is a federal agency within the Department of Health and Human Services (HHS) responsible for protecting and promoting public health. For medical devices, FDA ensures products are safe and effective before they reach patients.

FDA product centers:
- CDRH - Center for Devices and Radiological Health (medical devices)
- CDER - Center for Drug Evaluation and Research
- CBER - Center for Biologics Evaluation and Research
- CFSAN - Center for Food Safety and Applied Nutrition
- CVM - Center for Veterinary Medicine
- NCTR - National Center for Toxicological Research

Medical device pathways:
1. 510(k) Premarket Notification - Most common, demonstrates substantial equivalence
2. De Novo Classification - For novel low-moderate risk devices
3. Premarket Approval (PMA) - For high-risk Class III devices
4. Humanitarian Device Exemption (HDE) - For rare conditions

Key FDA requirements for devices:
- Establishment Registration (annual)
- Device Listing (with updates)
- Quality System Regulation (21 CFR 820)
- Medical Device Reporting (MDR)
- Unique Device Identification (UDI)

FDA vs "FDA Approved":
Most devices are "FDA cleared" (510(k)) not "FDA approved" (PMA). Only Class III devices with PMA are technically "approved."

Global influence:
FDA is considered the gold standard for medical device regulation. Many countries accept FDA clearance/approval as supporting evidence for their own regulatory submissions.