The Center for Biologics Evaluation and Research (CBER) regulates the medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products. CBER also regulates all HIV test kits used both to screen donor blood, blood components and cellular products, and to diagnose, treat and monitor persons with HIV and AIDs.

All CBER device applications should be addressed to:

Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002

(Please do not send CBER device applications to the Center for Devices and Radiological Health {CDRH})

---

Approval Process and Related Information

• Devices Regulated by the Center for Biologics Evaluation and Research
• Premarket Approval (PMA) Process (CBER)
  Device Application Submissions
• Biologic Forms

Approved Products

• Cleared 510(k) Submissions with Supporting Documents
• 510k Blood Establishment Computer Software
• Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents
• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
• Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases

Device Guidances, Rules and Other Publications

• Annual Reports for Approved Premarket Approval Applications (PMA); Guidance for Industry and Food and Drug Administration Staff
  12/16/2019
• Real-Time Premarket Approval Application (PMA) Supplements; Guidance for Industry and FDA Staff
  12/16/2019
• Humanitarian Device Exemption (HDE) Program; Guidance for Industry and Food and Drug Administration Staff
  9/6/2019
• Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment; Guidance for Industry
  8/2018
• Premarket Assessment of Pediatric Medical Devices; Guidance for Industry and FDA Staff
  3/24/2014
• Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
  6/25/2010
• Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF Version)
  12/11/2008
• Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions - Guidance for Industry and FDA Staff
  9/14/2007
• In Vitro Diagnostic Multivariate Index Assays - Draft Guidance for Industry, Clinical Laboratories, and FDA Staff
  7/26/2007
• Bundling Multiple Devices or Multiple Indications in a Single Submission; Guidance for Industry and FDA Staff
  6/22/2007
• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and FDA Staff
  5/11/2005
• Quality System Information for Certain Premarket Application Reviews - Guidance for Industry and FDA Staff
  2/3/2003
• General Principles of Software Validation - Final Guidance for Industry and FDA Staff
  1/11/2002
• Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA); Guidance for Industry
  2/17/1999
• Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices; Final Rule
  11/20/1998
• Natural Rubber-Containing Medical Devices; User Labeling; Final Rule
  5/6/1998