Devices Regulated by the Center for Biologics Evaluation and Research
Jurisdiction of medical device review by the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) is governed by the FDA Intercenter Agreement between CBER and CDRH (October 31, 1991).
CBER regulates medical devices related to licensed blood and cellular products by applying appropriate medical device laws and regulations. The medical devices regulated by CBER are intimately associated with the blood collection and processing procedures as well as the cellular therapies regulated by CBER. CBER has developed specific expertise in blood, blood products and cellular therapies and the integral association of certain medical devices with those biological products supports the regulation of those devices by CBER.
Federal Register Notices related to Devices Regulated by CBER are listed below.
Federal Register Notices
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications
Federal Register /Vol. 75, No. 26 /Tuesday, February 9, 2010 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications - 11/9/2007
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications - 8/24/2007
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications - 3/15/2007
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications - 6/3/2005
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications - 6/30/2004
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications - 5/27/2004
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications - 1/6/2004
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; List of Premarket Approval Actions - 3/31/2000
Resources For You
- Cleared 510(k) Submissions with Supporting Documents
- Substantially Equivalent 510(k) Device Information
- Complete List of Substantially Equivalent 510(k) Device Applications
- Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)
- Complete List of Currently Approved Premarket Approvals (PMAs)