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10 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.

  • Effects of Nanocrystalline Structure and Passivation on the Photoluminescent Properties of Porous Silicon Carbide

  • Jonathan E. Spanier, G. S. Cargill III, Irving P. Herman, Sangsig Kim, David R. Goldstein, Anthony D. Kurtz, Ben Z. Weiss
  • Journal:
    MRS Online Proceedings Library Archive / Volume 452 / 1996
    Published online by Cambridge University Press:
    15 February 2011, 491
    Print publication:
    1996

  • We present the results of an investigation of the dependence of the photoluminescence (PL) spectra on preparation conditions, the resulting microstructure, and post-anodization treatment of porous silicon carbide films which were formed from both p and n-type 6H-SiC substrates. Porous samples were prepared by anodic dissolution under different galvanostatic conditions, resulting in different porosities and crystallite sizes. Selected-area electron diffraction patterns taken on similarly prepared porous silicon carbide (PSC) samples confirmed that the films were monocrystalline. Transmission electron microscopy of as-anodized films revealed an isotropie porous network; a dependence of porosity and nanocrystallite size on porous layer formation current density was established. Some PSC samples were passivated using a short, thermal oxidation treatment. The effects of porosity and crystallite size, and of oxide passivation in these PSC films, on PL spectra and intensity were studied using a 365 nm Kr-ion laser as excitation. Under certain conditions, the spectrally integrated PL intensity of a passivated film is more than 450x that for the original bulk SiC substrate. PL spectra are presented, and possible mechanisms are discussed.