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 and 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 PMA application under Section 515 of the FDCA in order to obtain marketing clearance. Please note that some Class III preamendment devices may require a Class III 510(k).
Most Class III medical devices require a PMA. Section 515(c)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) specifies the required contents of a PMA. The PMA application content includes:
• full reports of all information, published or known to, or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective;
• a full statement of the components, ingredients, and properties and of the principle or principles of operation, of such device;
• a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of such device;
• an identifying reference to any performance standard under Section 514 which would be applicable to any aspect of such device if it were a Class II device, and either adequate information to show that such aspect of such device fully meets such performance standard, or adequate information to justify any deviation from such standards;
• such samples of such device and of components thereof as the Secretary may reasonably require, except that where the submission of such samples is impracticable or unduly burdensome, the requirement of this subparagraph may be met by the submission of complete information concerning the location of one or more such devices readily available for examination and testing;
• specimens of the labeling proposed to be used for such device; and
• such other information relevant to the subject matter of the application as the Secretary, with the concurrence of the appropriate panel under Section 513, may require.
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. A facility inspection verifying the manufacturing systems present to manufacture the medical device is usually performed prior to FDA PMA approval. 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.
The regulation governing premarket approval is located in Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval. A Class III device that fails to meet PMA requirements is considered to be adulterated under Section 501(f) of the FD&C Act, and cannot be marketed.