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FDA issues draft guidance to update policy on categorizing investigational device exemption devices to assist CMS coverage decisions
  • Loeb & Loeb LLP
  • USA
  • June 12 2016

The draft guidance will amend the FDA's 20-year-old policy for categorizing devices as experimental or nonexperimental based on initial questions of


FDA issues draft guidance detailing benefit-risk approach when considering medical device availability, compliance and enforcement decisions
  • Loeb & Loeb LLP
  • USA
  • June 12 2016

The draft guidance aims to shed light on appropriate responses to nonconforming product or regulatory compliance issues related to diagnostic and