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Posts tagged ‘FDA Medical Devices’

In early February, the U.S. Food and Drug Administration (FDA) sent e-mails to medical device establishments that had not yet renewed their FDA registrations for fiscal year (FY) 2016.  The e-mails state that “Failure to complete your annual registration by February 22nd, 2016, will result in your establishment being removed from FDA’s database of active […]

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.  […]

Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products that were offered for sale prior to September 2, 2014 are required to submit premarket notification (510(k)) for those products to the U.S. Food and Drug Administration (FDA) by August 26, 2015 if they wish to continue selling them in the United […]

On March 24, 2015, the U.S. Food and Drug Administration (FDA) offered a webinar to review the agency’s guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” that was published last week.  The webinar was presented by Elaine Mayhall from FDA’s Office of Device Evaluation and Geetha Jayan from FDA’s Office of […]

On Monday, February 16, 2015, the U.S. Food and Drug Administration (FDA) purged approximately 2,628 medical device establishments that did not complete their annual registrations by the deadline from its registration database.  Owners and operators of companies that produce and distribute medical devices for use in the United States are required to register with FDA […]

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