What is a Premarket Approval (PMA)?
• A PMA is an application submitted to FDA to request approval to market, or continue marketing, a class III medical device. • PMA approval is based on scientific evidence providing a reasonable assurance that the device is safe and effective for its intended use or uses. For IVDs, there is a unique link between safety and effectiveness since the safety of the device is not generally related to contact between the device and patient. For IVD products, the safety of the device relates to the impact of the device’s performance, and in particular on the impact of false negative and false positive results, on patient health. • FDA reviews PMA submissions in a 180-day timeline. If there are unaddressed scientific issues, the review scientists can ask for additional information and put the submission temporarily on hold. If a product is a first of a kind, or if it presents unusual issues of safety and effectiveness, it is generally reviewed before it is approved by an advisory panel of outsi
