Reference information for regulations that apply to the Plasma industry.

Food and Drug Administration (FDA)

Code of Federal Regulations (CFR)

  • CFR 21 Part 606 — Current Good Manufacturing Practice for Blood and Blood Components
  • CFR 21 Part 630 — Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
  • CFR 21 Part 640 — Additional Standards for Human Blood and Blood Products
  • CFR 21 Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers
  • CFR 21 Part 820 — Quality System Regulation

Guidances

  • FDA-2021-D-1158 — Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

Plasma Protein Therapeutics Association (PPTA)