Premarket approval (PMA) is the FDA process to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, or of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
PMA is the most stringent type of device marketing application required by the FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device. The PMA owner, however, can authorize the use of its data by another.
FDA regulations provide 180 days for the agency 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 the FDA with the committee's recommendation on whether FDA should approve the submission.
We help the medical device and IVD industries with Pre-Market Approval submissions covering Modular and Traditional approaches and also provide help with PMA supplements including 180 days supplement, Special Supplements, 30-day notices, 135 days supplements.