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Posts tagged ‘510(k)’

On August 4, 2015, the U.S. Food and Drug Administration (FDA) published an updated “Refuse to Accept Policy for 510(k)s.”  This policy will become effective on October 1, 2015, and will replace the previous version of the policy published in 2012.  When FDA receives a 510(k) submission, the agency first checks the submission for completeness.  […]

On December 22, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance regarding the transfer of a premarket notification (510(k)) clearance.  If a medical device establishment sells a device that is not 510(k)-exempt to another company, it can include the 510(k) clearance for the device along with  the sale.  As long as […]

On August 1, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements.” FDA has identified certain class I and II devices for which risks, safety, and effectiveness have been established well enough for the agency […]

On August 14, FDA issued a draft guidance regarding the evaluation of automatic class III designation, otherwise known as de novo classification. The guidance details a recent change in the requirements for submitting de novo classification request.  A new type of device is automatically classified as class III, regardless of its risk, if no similar […]

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