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类别: REGULATORY PATHWAYS
上市前批准(PMA)
FDA最严格的器械上市途径，适用于III类器械。PMA要求提供证明安全性和有效性的临床证据，不同于510(k)的实质等效标准。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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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