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FDA finalizes clarifying process for classifying combination products as drugs, biologics or medical devices
  • Loeb & Loeb LLP
  • USA
  • October 30 2017

The FDA’s finalized guidance places a particular focus on cases in which a combination product may be classified as a drug or device. The document

FDA issues draft guidance to update policy on categorizing investigational device exemption devices to assist CMS coverage decisions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The draft guidance will amend the FDA's 20-year-old policy for categorizing devices as experimental or nonexperimental based on initial questions of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 guidance explains how the agency will determine whether a 510(k) submission should be accepted for substantive review
  • Loeb & Loeb LLP
  • USA
  • August 31 2015

The regulator issued guidance to go over the necessary elements and contents of a complete 510(k) submission in a bid to enhance the consistency of