PMA
Also known as: Premarket Approval, PMA Pathway
Premarket Approval: the FDA review process for Class III medical devices, which requires evidence of safety and effectiveness, usually from clinical trials.
Full Definition
PMA is the most demanding FDA pathway for medical devices. It applies to Class III devices, which support or sustain life, are of substantial importance in preventing impairment of health, or present a potential unreasonable risk of illness or injury. Approval rests on valid scientific evidence that the device is safe and effective for its intended use. Most PMAs require data from a pivotal clinical trial.
Compared with 510(k) clearance, a PMA takes longer and costs more, which changes the funding and timeline a team must plan for. A device that goes through a 510(k) is FDA cleared. A device that goes through a PMA is FDA approved.
A company developing an implantable cardiac device confirms that it is Class III. It plans a pivotal clinical trial to support a PMA and sizes its Series A to fund the trial and the submission.