Premarket Approval (PMA) for CBER-Regulated Products
Center for Biologics Evaluation and Research (CBER) regulates medical devices related to licensed blood and cellular products while 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.
Jurisdiction of medical device review by the CBER is listed at Devices Regulated by the Center for Biologics Evaluation and Research | FDA
Please do not send CBER device applications to the Center for Devices and Radiological Health (CDRH). All CBER device applications must be submitted in accordance with the CBER Regulatory Submissions - Electronic and Paper website information.
What are Premarket Approvals (PMAs)?
A PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act to obtain marketing approval.
The regulation governing premarket approval is located in Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval of Medical Devices. A Class III device that fails to meet PMA requirements is considered adulterated under section 501(f) of the FD&C Act and may not be marketed.
CBER Premarket Approvals
- Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents
- Complete List of Currently Approved Premarket Approvals (PMAs)
Preparing a Premarket Submission
The FDA has developed several different types of resources to help you prepare a premarket submission. These include the following:
- CDRH Learn: A video-based series of teaching modules, seminars, and recorded webinars that cover a variety of policy and guidance efforts.
- FDA’s Q-Submission Program: Prospective applicants of future premarket submissions may request feedback from the FDA through a Pre-Submission, which is part of the Q-Submission Program. Information about this program may be found in the FDA guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. We encourage you to read our online information and other available resources prior to sending any request for feedback.
- FDA Breakthrough Devices Program: This voluntary program helps patients have more timely access to certain medical devices that treat or diagnose a life-threatening or irreversibly debilitating condition by speeding up their development, assessment, and review. Devices subject to Premarket Approval applications (PMAs), premarket notifications [510(k)], or De Novo classification requests may be eligible. Sponsors can send a Breakthrough Designation request for their device at any time prior to sending the device’s marketing submission.
CBER Approved Products
- Substantially Equivalent 510(k) Device Information
- Evaluation of Automatic Class III Designation (De Novo) Summaries (CBER)
- 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
- How to Study and Market Your Device
- Premarket Approval (PMA)
- When a PMA is Required
- PMA Application Content
- PMA Review Process
- Data Standard and Terminology Standards for Medical Devices
- PMA Guidance Documents
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
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