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CATEGORY: REGULATORY PATHWAYS
Premarket Approval (PMA)
The most stringent FDA device marketing pathway, required for Class III devices. PMA requires clinical evidence demonstrating safety and effectiveness, unlike the 510(k) substantial equivalence standard.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
PMA applies primarily to Class III devices that support or sustain life, are implanted, or present potential unreasonable risk of illness or injury—when 510(k)/De Novo is not appropriate.
PROCESS / STEPS
- Confirm Class III designation and PMA product code expectations.
- Plan clinical evidence early (IDE if needed) with primary endpoints tied to intended use.
- Compile manufacturing, design history, and risk management (ISO 14971) packages.
- Submit PMA modules or traditional PMA; manage panel review if convened.
- Complete inspections, labeling negotiations, and post-approval study commitments.
EXAMPLES
- Implantable pacemakers, many drug-eluting stents, and certain high-risk implants require PMA.
RELATED GUIDES & TOOLS
SOURCES
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