On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015.   This guidance is a first for the FDA and comes as a product of negotiations with the medical device industry over Medical Device User Fee Amendments of 2012 (MDUFA III).  The lists of guidance is broken into an A-List (which the FDA intends to publish) and a B-List (which the FDA will publish “as resources permit”).  There is a third list of historically released guidance – from 2005, 1995 and 1985 – that are “subject to focused retrospective review.”  Some of the key A-List items are:

  • Framework for Regulatory Oversight of Laboratory Developed Tests
  • FDA Notification and Medical Device Reporting for Laboratory Developed Tests
  • Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements
  • Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Need for Life Threatening of Irreversibly Debilitating Diseases or Conditions

 Important B-List items include:

  • Transfer of Ownership of a Premarket Notification: Questions & Answers
  • Direct Access Genetic In Vitro Diagnostics Testing (also known as Direct to Consumer Genetic Testing)
  • 3D Printing (Technical)

Comments may be submitted on any or all of the lists.  There was little reaction to the guidance from Capitol Hill.  However, the guidance was released the same week the newly-seated 114th Congress began its discussions to repeal the medical device tax and prepared to release draft proposals and legislation under the 21st Century Cures Initiative – which is related to the “discovery, development and delivery of treatment and cures.”

Posted by Vince Sampson

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