PMA

Premarket Approval applies to Class III devices: those supporting/sustaining life, of substantial importance in preventing impairment of human health, or presenting unreasonable risk of illness/injury (e.g. implanted defibrillators, certain heart valves, some IVDs). The PMA must demonstrate, with valid scientific evidence (typically randomised clinical trials), reasonable assurance of safety and effectiveness.

PMA submissions include device description, non-clinical and clinical investigations, manufacturing information, labelling and a financial certification. FDA review is 180 days statutory, often much longer; advisory panel review is common.

V5's DHF + design-controls workstreams support PMA-grade evidence assembly.