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  2. Vaccines, Blood & Biologics
  3. Development & Approval Process (CBER)
  4. Device Submissions for CBER-Regulated Products
  5. Premarket Notification 510(k) Process for CBER-Regulated Products
  6. Devices Regulated by the Center for Biologics Evaluation and Research
  1. Premarket Notification 510(k) Process for CBER-Regulated Products

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

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