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Posts tagged ‘FDA Medical Devices’

A inicios de Febrero, la U.S. Food and Drug Administration (FDA) envió correos electrónicos a los establecimientos de dispositivos médicos que no habían renovado sus registros para el año fiscal 2016. Los correos electrónicos mencionan que “No completar su renovación de registro anual antes del 22 de Febrero de 2016, causará el retiro de su […]

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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