FDA Debrief: CDRH Veteran Amputee Device Workshop, October 31, 2016 – Drug and Device Digest


KEY Concepts

  • Use / Assess TPLC (Total Product Life Cycle)
  • Engagement to improve patient experience – better understand patient preference and patient input
  • Include amputee preference in B/R assessment

DR. VIVEK PINTO:  Branch Chief, PMDB

  • Non-invasive prosthetic devices are generally Class I Exempt devices
  • Must comply with general controls: Components for prosthetic limbs, Assembled systems
  • TPLC
    • Novel prosthetics – less knowledge about safety and effectiveness : Greater premarket purview
    • Customary prosthetics- history of safety and effectiveness – Greater postmarket purview


  • Functional Outcome measures
  • Patient-centered, Clinically-meaningful test methods
  • DARPA haptics, VR platform 


  • IoT/Interoperability: Data/Specification? Include in label what is / is not compatible
  • Differences in classification of ‘similar’ devices: FR publishes reviews, FDA will note to increase transparency
  • Patients vs Physician measures of performance: Website for tests used by physicians?
  • Lack of readily available information of approves/cleared prosthetics
  • Johns Hopkins University Patient Preference methods: Incorporate patient & caregiver voice : Facts vs Values, Measuring choices
  • LIM innovations: Optimal Socket design , R&D approach to incorporate user feedback: Improve comfort stds, Understanding patient journey post-amputation, connected tech to prosthetics, moderated interviews
  • FDA-CMS considerations upfront

VA Amputation Society (ASoc) Clin perspectives on amputation care

    • Enhance quality and consistency of amputation care
    • Prosthetic dissatisfaction and abandonment
    • Tech advances outpaces research

Prosthesis prescription considerations

  • Must be based on the Veteran not the available technology
  • Prosthetic education and training essential to successful outcomes
  • Greater need for highly specialized teams with advanced technology


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