Webinar – Draft Guidance: 'Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions'

On Monday, July 11, 2016, the FDA will host a webinar to share information and answer questions about its draft guidance entitled ‘Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.’ This draft guidance released on June 15, 2015, focuses on the factors the FDA may consider when making decisions…

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…