FDA updates guidance for its 510(k) Refuse to Accept Policy…

FDA updates guidance for its 510(k) Refuse to Accept Policy…

FDA released updated guidance addressing its screening acceptance process for 510(k) notifications. FDA has also made corresponding changes to the associated ‘Acceptance Checklist for 510(k)s’.

The revised guidance provides updates explaining the current procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. The new guidance is effective on October 1, 2015 and supersedes three predecessor documents from 1993, 1994, and 2012. Links to the revised guidance and updated checklists are provided below:

 

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.pdf

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm071360.htm

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