Commenters Note RWE Draft Guidance Could be Burdensome to Device Manufacturers

The FDA’s draft guidance describing how device manufacturers can use real-world evidence (RWE) to support regulatory applications is a good start, but needs some refinement to avoid becoming a burden on manufacturers, according to many of the 28 comments posted.

The Medical Device Manufacturers Association (MDMA) offered the most detailed criticisms, saying that the level of detail required — especially for low-risk devices — could be “burdensome.” And the draft’s suggestion that extant literature might no longer be considered an acceptable form of RWD is very concerning.

AdvaMed suggested that the FDA clarify exactly what entities will need to apply the guidance. “While the document is a positive step forward, the continued ambiguity for specific RWD sources and methods leaves significant room for interpretation. This increases the possibility of continued differences in expectations between sponsors and the Agency.”

Read the draft guidance and comments here.

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