February 20, 2024
The Alliance submitted comments supporting the intentions of FDA's draft guidance Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices, which would make use of real-world data and RWE for clinical trials and in expanding indications for use on already approved or cleared devices. We reminded the FDA that CMS and private payers do not accept this type of data for most products - including medical devices - for coverage purposes. As such, even if the FDA adopts/permits real world data/evidence for regulatory decision making, unless CMS and commercial payers also accept real world data/evidence, manufacturers would need to provide one type of evidence for the FDA and another for payers for coverage and payment purposes. The Alliance encouraged the FDA to dialogue with CMS and offered to serve as a resource and convener so that dialogue focused on  realistic and workable solutions can move forward.

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