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On Monday, July 11, 2016, the FDA hosted a webinar to share information and answer questions about its draft guidance entitled 'Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.' This draft guidance released on June 15, 2016, focuses on the factors the FDA may consider when making decisions related to compliance and enforcement actions for a specific medical device company, or when making decisions that may affect a medical device's availability on the market in general. The agency believes that greater transparency about the process and purpose behind such assessment will maximize patient safety by helping industry improve their medical device products and by increasing access to high quality medical devices for patients.

Target audience: Industry

If you have any general questions about the FDA's regulation of medical devices, please contact CDRH's Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health