THE SGS FDA 3P510(K) PROGRAM
• Introduction: Through the SGS third-party notified body, review the medical devices with lower risk levels, so that the FDA can focus more on the review of high-risk medical devices to ensure the safety and efficacy of medical devices on the market.
• Application process: The manufacturer confirms whether the medical device applied for is an item in the SGS third-party review list ⇒ Fill out the questionnaire to apply ⇒ SGS review the feasibility and complete the level acceptance analysis ⇒ Open the schedule review
• Applicable customer: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm
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