FDA Finalizes Real-world Evidence Guidance for Device Sponsors, May Consider More RWE in Product Reviews

On December 17, the U.S. Food and Drug Administration (FDA) finalized its long-awaited guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” clarifying how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality and provenance to be accepted as “real-world evidence” (RWE) suitable for review and reliance on by FDA in regulatory decision-making for medical devices. This comes after FDA issued a press release on…
By: Hogan Lovells