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 medical devices:
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 FD&C Act in order to obtain marketing clearance.
NOTE: PMA is the most stringenttype of device marketing application required by FDA, and 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).
FDA regulations allow 180 days for FDA review of the PMA submission, but, in reality, the review time is typically longer. Before making the decision, an 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.
PMA is required for any life-supporting device, or any device that has been determined to have high risk of injury to patients. This process takes longer, and since it frequently involves a clinical trial, is considerably more expensive than the 510(k) process.
Note: On the positive side, a PMA-cleared product may have more commercial value than a 510(k)-cleared product, because a potential competitor with a similar product will also be required to submit a PMA, thereby establishing a barrier to entry.
For detailed FDA guidance on the PMA regulations and submission process, visit this link.