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Generics Bulletin

Medtech Insight

FDA Finalizes First Two Guidances For 510(k) Pathway That Uses Performance Measurements

Aug 14 2020

• By Ferdous Al-Faruque

Performance measurement or level with caliper on computer notebook

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United States Regulation Approvals Compliance FDA Guidance Documents Innovation Review Pathway Safety Renal Gynecology & Urology Surgical Procedures Medical Device

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