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  • 10 - A “DESI” for Devices?

  • from Part III - Designing Medical Device Regulations
  • Edited by I. Glenn Cohen, Harvard Law School, Massachusetts, Timo Minssen, University of Copenhagen, W. Nicholson Price II, University of Michigan, Ann Arbor, Christopher Robertson, Boston University, Carmel Shachar, Harvard Law School, Massachusetts
  • Book:
    The Future of Medical Device Regulation
    Published online:
    31 March 2022
    Print publication:
    07 April 2022, pp 129-140
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  • Summary

    The FDA has put guidance in place detailing how it will use RWE while regulating medical devices and published a framework to explain its use of RWE in regulating drugs. Inside the agency, influential officials resist the use of RWE in regulatory decision-making while championing the importance of randomized controlled trials. Outside, a growing body of literature highlights the challenges involved in securing high-quality evidence postapproval. Growing safety concerns about several medical devices — discovered only after real world use — has renewed calls for more rigorous pre and postmarket evaluation