by
Brendon Nafziger, DOTmed News Associate Editor | September 09, 2009
FDA thinks third-party
inspections will be more
convenient for medical
device manufacturers
The FDA released revised guidelines last month for accrediting third-party inspectors of medical device manufacturers.
As required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and an amendment passed in 2007, some manufacturers now have the option of choosing independent inspectors instead of ones from the FDA to make sure their establishments are in compliance with FDA safety and health requirements. Independent inspectors will be more convenient for manufacturers and will ease the burden on FDA resources, according to the FDA.
Since the program went into effect, the FDA has accredited 16 organizations, which have conducted over 90 independent inspections.
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To be eligible for independent inspections, a manufacturer must previously have received a favorable report from the FDA.
More information on the new regulations can be found here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089702.htm
To learn about becoming an inspector, or hiring one, visit the FDA's website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ThirdPartyInspection/ucm125410.htm#overview
