US FDA In Brief: Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies

The following quote is attributed to William Maisel, M.D., chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health:

“Today, the FDA issued two draft guidance documents regarding the continuous surveillance of certain FDA approved and cleared devices. When final, these guidance documents will help increase transparency and assist reporting and timely completion of studies on the safety and effectiveness of certain devices.

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