Tuesday, December 19, 2023

FDA Issues Updated Real World Evidence Guidance [Also 3rd Party Review] (Drafts for Comment)

FDA has an existing guidance document for real world evidence (RWE) but now they've issued an update for public comment.  It's directed at medical device (or potentially diagnostics) studies.

Find the FDA web page, draft document, and Fed Reg link here:


Comments to 2/20/2024.

  • Early coverage at MedTechDive here.
  • In September 2023, we saw final new RWE guidance for biopharma - here.
  • Also in September 2023, we saw draft guidance for "clinical data in 510(k) applications," here.
  • A subscription-only article at BioWorld here.
FDA also issues draft guidance on third party review of 510k and third party review of emergency (EUA) submissions. Here.

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