510(k) Process (CBER)
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 - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria - Guidance for Industry, FDA Staff, and Third Parties
8/6/2009 - 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
Follow CBER
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
(800) 835-4709
(240) 402-8010
For Updates on Twitter, follow @fdacber