Premarket Approval (PMA)

What is premarket approval?

PMA is the FDA's process for evaluating the safety and effectiveness of Class III devices — those that support or sustain human life, are of substantial importance in preventing impairment of health, or present a potential unreasonable risk. Unlike a 510(k), a PMA does not compare the device to a predicate: the applicant must independently demonstrate reasonable assurance of safety and effectiveness with valid scientific evidence, typically including data from a clinical investigation conducted under an investigational device exemption.

What does a PMA contain?

Technical sections covering nonclinical laboratory studies and clinical investigations, complete manufacturing information, proposed labeling, and often bibliographies of relevant published reports. The FDA may inspect manufacturing facilities before approval and may take the application to an advisory panel of outside experts for novel questions.

How long does PMA review take?

The statutory review period is 180 days, with MDUFA performance goals structured around it, but major deficiency letters, panel involvement and facility inspections mean total calendar time is commonly much longer. Modular PMA submissions and pre-submission meetings are the standard tools for de-risking the timeline.

What obligations follow approval?

A PMA is device- and manufacturer-specific and lives on after approval: changes affecting safety or effectiveness require PMA supplements, annual reports are mandatory, and the FDA can impose post-approval studies as conditions of approval. This continuing-obligation structure is a real cost difference from the 510(k) world and belongs in any United States market-entry budget for a Class III product.