CDRH Sets Fiscal Year 2017 Guidance Priorities

The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Center for Devices and Radiological Health (CDRH) has released a list of 12 final guidance documents and four drafts that it intends to publish during fiscal year 2017. The center, which is the arm of the Food and Drug Administration (FDA) that regulates the medical device industry, also developed a second list of guidance items that will be developed as “resources permit.” The so-called “A-list” covers several hot topics in the industry, including the use of real-world evidence to support regulatory decision making, which is also a regulatory science priority for 2017, as well as device cybersecurity, interoperability, and the use of benefit-risk factors. However, with uncertainty surrounding President-elect Donald Trump's pick for FDA commissioner and his administration’s healthcare policies in general, it's unclear whether these topics will remain priorities and how they might play out.

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Source: AAMI