The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on real-world evidence (RWE).

Responding to the Center for Devices and Radiological Health’s (CDRH’s) “Fiscal Year 2017 (FY 2017) Proposed Guidance Development,” the medical device trade group submitted its recommendations for how guidances should be prioritized. In addition to recommending revisions to existing guidances, AdvaMed also suggests which guidances should be withdrawn.

Guidance recommendations ranked

AdvaMed ranked each recommendation with a “high,” “medium,” or “low” priority based on how it affects medical device manufacturer members.

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