Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies

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Announcing Final Guidance on Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and FDA Webinar on the Final Guidance

On July 21, 2016, the FDA will hold a webinar for industry to review the Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” final guidance document. The recommendations in this final guidance clarify and update how medical device developers may use…

Webinar – Draft Guidance: 'Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions'

On Monday, July 11, 2016, the FDA will host a webinar to share information and answer questions about its draft guidance entitled ‘Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.’ This draft guidance released on June 15, 2015, focuses on the factors the FDA may consider when making decisions…

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:…