Vaccines, Blood & Biologics
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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})
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Approval Process and Related Information
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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
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Device Guidances, Rules and Other Publications
Assay Migration Studies for In Vitro Diagnostic Devices
1/5/2009Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
8/7/2008Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
3/7/2008Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices
3/7/2008Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
11/30/2007Medical Devices; Hematology and Pathology Devices; Reclassification of Automated Blood Cell Separator Device Operating by Filtration Principle from Class III to Class II
2/28/2003Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
11/29/2007Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
10/29/2007Guidance for Industry and FDA Staff - Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
9/13/2007Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay
8/8/2007Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
8/8/2007Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays
7/24/2007Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission
6/22/2007Assessing 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
2/25/2003Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
3/26/2007Annual Reports for Approved Premarket Approval Applications (PMA)
10/26/2006Real-Time Premarket Approval Application (PMA) Supplements
4/28/2006Draft Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments; Withdrawal of Guidance
6/28/2005Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
5/12/2005Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
11/30/2004Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA
11/17/2004Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)
5/28/2004FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
5/20/2004Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
11/21/2003Premarket Approval Application Modular Review
10/31/2003Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay
10/30/2003FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
10/8/2003Premarket Assessment of Pediatric Medical Devices
7/24/2003Guidance 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
7/3/2003Premarket Approval Application Filing Review
5/1/2003Guidance 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
4/28/2003Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
2/3/2003The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry
10/3/2002General Principles of Software Validation; Final Guidance for Industry and FDA Staff
1/11/2002Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers
7/19/2001Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)
7/19/2001Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components
7/19/2001Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
7/11/2001Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices
11/22/2000Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (PDF - 40KB)
7/15/1999List of Documents Issued by the FDA That Apply to Medical Devices Regulated by the Center for Biologics Evaluation and Research
4/26/1999Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (PDF - 369KB)
2/17/1999Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices; Final Rule
11/20/1998Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices; Proposed Rule
6/8/1998Natural Rubber-Containing Medical Devices; User Labeling; Final Rule
5/6/1998
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
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
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