-
Vaccines, Blood & Biologics
-
Resources for You
-
-
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:
FDA/CBER
1401 Rockville Pike
HFM-99, Room 200N
Rockville, MD 20852-1448
(Please do not send CBER device applications to the Center for Devices and Radiological Health {CDRH})
-
Approval Process and Related Information
-
-
Approved Products
- Cleared 510(k) Submissions with Supporting Documents
- 510(k) Blood Establishment Computer Software
- Premarket Approvals with Supporting Documents
- Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
- Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases
-
-
Device Guidances, Rules and Other Publications
- Assay Migration Studies for In Vitro Diagnostic Devices
1/5/2009 - Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
8/7/2008 - Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
3/7/2008 - Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices
3/7/2008 - Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
11/30/2007 - Medical Devices; Hematology and Pathology Devices; Reclassification of Automated Blood Cell Separator Device Operating by Filtration Principle from Class III to Class II
2/28/2003 - Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
11/29/2007 - Draft Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions
10/29/2007 - Guidance for Industry and FDA Staff - Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
9/13/2007 - Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay
8/8/2007 - Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
8/8/2007 - Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays
7/24/2007 - Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission
6/22/2007 - Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
2/25/2003 - Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
3/26/2007 - Annual Reports for Approved Premarket Approval Applications (PMA)
10/26/2006 - Real-Time Premarket Approval Application (PMA) Supplements
4/28/2006 - Draft Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments; Withdrawal of Guidance
6/28/2005 - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
5/12/2005 - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
11/30/2004 - Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA
11/17/2004 - Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)
5/28/2004 - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
5/20/2004 - Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
11/21/2003 - Premarket Approval Application Modular Review
10/31/2003 - Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay
10/30/2003 - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
10/8/2003 - Premarket Assessment of Pediatric Medical Devices
7/24/2003 - Guidance for Industry and FDA Staff - Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices
7/3/2003 - Premarket Approval Application Filing Review
5/1/2003 - Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria
4/28/2003 - Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
2/3/2003 - The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry
10/3/2002 - General Principles of Software Validation; Final Guidance for Industry and FDA Staff
1/11/2002 - Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers
7/19/2001 - Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)
7/19/2001 - Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components
7/19/2001 - Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
7/11/2001 - Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices
11/22/2000 - Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (PDF - 40KB)
7/15/1999 - List of Documents Issued by the FDA That Apply to Medical Devices Regulated by the Center for Biologics Evaluation and Research
4/26/1999 - Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (PDF - 369KB)
2/17/1999 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices; Final Rule
11/20/1998 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices; Proposed Rule
6/8/1998 - Natural Rubber-Containing Medical Devices; User Labeling; Final Rule
5/6/1998
-
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
-
-
-