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2 results

  • 18 - Professional Self-Regulation in Medicine

  • from Part V - Medical and Legal Oversight of Medical Devices
  • 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 244-255
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  • Summary

    Not all clinical trials of in-dwelling Class III medical devices (e.g., DBS) will successfully demonstrate safety and efficacy, conditions necessary for FDA approval. Other trials may be successful, but the study sponsor and investigators may decide not to bring the device to market. There is scant regulatory guidance about sponsor or investigator posttrial obligations and little case law. While industry norms tend to govern posttrial access to pharmaceuticals, and industry sponsors routinely offer some degree of access, these norms are neither established nor directly analogous to questions of posttrial access to in-dwelling Class III medical devices. Legal clarity is important, given that such devices remain in a participant’s body and may require ongoing maintenance, surveillance, replacement, or explanation, and uncertainty about posttrial access may dissuade prospective participants from trial enrollment, potentially thwarting the development of innovative devices.