Rx REPORT

U.S. FDA Issues Draft Guidance on The Least Burdensome Provisions: Concepts and Principles

On December 15, 2017, FDA issued a new, draft guidance that describes how FDA intends to implement provisions enacted by Congress to pursue the “least burdensome” means of assuring the safety and effectiveness of new devices so that innovations that benefit patients can reach them more efficiently.  FDA defines least burdensome to be the “minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time”.  The new draft guidance also explains FDA’s regulatory approach and delineates guiding principles that they propose to apply across the total product lifecycle, beyond what Congress has required, including all device-related applications and interactions with medical device industry.

According to FDA, these least burdensome principles will apply to:

  • Premarket submissions, including PMAs, premarket notifications (510(k)s), de novo requests, humanitarian device exemption (HDE) applications and investigational device exemption (IDE) applications
  • Additional Information and Major Deficiency letters
  • Q-submissions
  • Informal or interactive inquiries regarding device development
  • Panel review and recommendations
  • Postmarket surveillance and post-approval studies
  • Reclassifications and exemptions
  • Guidance documents and their application
  • Compliance-related interactions
  • Regulation development

When final, this document will supersede “The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles”, issued on October 4, 2002.

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