FDA Pre Market Approval (PMA)

The purpose of a pre-market approval (PMA) is to demonstrate the safety and efficacy of a Class III device through a scientific, regulatory documentation to FDA. According to FDA, "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." Therefore, in addition to the General and Special controls, these devices need PMA to obtain marketing clearance.

A PMA should contain sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is like a private license granting permission to market the device in question. The PMA applicant should ensure that the documentation is scientifically sound and presented in an organized manner. The PMA is usually contains technical sections organized into:

(i) Non-clinical Laboratory Studies Section - microbiology, toxicology, immunology, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests.
(ii) Clinical Investigations Section - study protocols, safety and effectiveness data, adverse reactions and complications, device failures and replacements, patient information, patient complaints, tabulations of data from all individual subjects, results of statistical analyses, and any other clinical investigations.

The FDA specifies a timeline of 180 days to process a PMA, though it usually takes longer. The FDA, during this time, reviews the data, discusses with an appropriate FDA committee and makes a determination. After announcing the result, approval or denial of the PMA to the applicant, the FDA posts the data based on which the decision was made on the Internet and gives 30 days for petitioning a reconsideration of the decision.