Premarket Approval (PMA)
The most stringent FDA regulatory pathway for medical devices, required for Class III devices that pose the highest risk. PMA requires clinical trial data demonstrating safety and effectiveness, unlike 510(k) which only requires substantial equivalence.
Premarket Approval (PMA) is the FDA process for evaluating 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 health, or present a potential unreasonable risk of illness or injury. Examples include implantable pacemakers, breast implants, and some diagnostic imaging systems.
PMA vs. 510(k)
While 510(k) clearance requires demonstrating substantial equivalence to a predicate device, PMA requires an independent demonstration of safety and effectiveness through clinical evidence. The PMA process is significantly longer (180-day FDA review vs. 90 days for 510(k)), more expensive, and requires well-controlled clinical studies. PMA supplements are required for any significant changes to the device after approval.
PMA in tender compliance
When a tender specifies an FDA-regulated Class III device, procurement teams verify the PMA approval number (e.g., P210001), the approved Indications for Use, and any conditions of approval. PMA-approved devices may also carry post-approval study requirements that affect long-term availability and product changes.