Medical Device Premarket Approval (PMA)

Premarket approval (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.

The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. The applicant is often the inventor/developer and ultimately the manufacturer.

FDA regulations provide 180 days to review the PMA and make a determination. In reality, the review time is normally longer. Before approving or denying a PMA, the appropriate FDA advisory committee may review the PMA at a public meeting and provide FDA with the committee's recommendation on whether FDA should approve the submission.

After FDA notifies the applicant that the PMA has been approved or denied, a notice is published on the Internet announcing the data on which the decision is based, and providing interested persons an opportunity to petition FDA within 30 days for reconsideration of the decision.

When a PMA is Required

PMA requirements apply to Class III devices, the most stringent regulatory category for medical devices. The CFR provides the device type name, identification of the device, and classification information.

Devices Used in Blood Establishments

The Center for Biologic, Evaluation, Research (CBER) has expertise in blood, blood products, and cellular therapies as well as the integral association of certain medical devices with these biological products. To utilize this expertise marketing and investigational device submissions (Premarket Notification, Premarket Approval, and Investigational Device Exemption) for medical devices associated with the blood collection and processing procedures as well as those associated with cellular therapies are reviewed by CBER.