Check the CDRH Customer Service Rating

This page provides real time results for CDRH’s customer satisfaction survey for the current rating period. About the Survey: On June 16, 2014, CDRH launched the Customer Satisfaction survey. The survey was revised between December 14, 2015 and February 1, 2016. CDRH measures customer satisfaction in six months intervals. CDRH Customer Satisfaction Rating: Results below…

Consumer Information on: AspireAssist

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: AspireAssistPMA Applicant: Aspire Bariatrics, Inc.Address:…

Dissemination of Patient-Specific Information from Devices by Device Manufacturers

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Webinar: Announcing Final Guidance on Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act and FDA Webinar on the Final Guidance on June 28, 2016

On June 28, 2016, the FDA will hold a webinar for industry to review the Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act guidance document.  Section 522 of the Federal, Food, Drug and Cosmetic Act (the Act) provides the FDA with the authority to require device manufacturers to conduct postmarket surveillance…