Medical device industry groups say the US Food and Drug Administration’s (FDA) draft guidance using real-world evidence (RWE) to support regulatory decision making for medical devices requires changes to make it workable, though some said the document was an improvement over the previous version.
The groups complained that the guidance is overly broad, should be better aligned with other efforts related to real-world data (RWD) and the agency’s guidance on RWD for pharmaceuticals, and that more information on data governance standards is needed.
The agency received 28 comments in response to the draft guidance. (RELATED: FDA proposes updated medtech RWE guidance, Regulatory Focus 19 December 2023)…
