Stakeholders comment on FDA draft real-world evidence guidance for medical devices

In seeking to advance the use of real-world evidence (RWE) in regulatory decision-making for medical devices, in December 2023 the FDA released a new draft guidance, ‘Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices’. The guidance aims to build on the previous FDA guidance issued in August 2017 and satisfies the requirements of the Food and Drug Omnibus Reform Act of 2022 (FDORA) as well as meeting the commitments set out in the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V). To ensure the guidance meets the expectations and requirements of all stakeholders, the FDA has...