FDA announces new drafted guidelines for easing regulation on medical device

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 - FDA

The U.S. Food and Drug Administration (FDA) has officially announced the availability of newly drafted guidelines that ease the process of regulating medical devices while maintaining the statutory requirements for safety clearance, according to a release from the FDA.  

By "least burdensome," the FDA refers to a minimum amount of information needed to adequately and promptly address a regulatory issue or question and include pre-market and post-market approaches. 

The guidelines apply, but is not limited to:  

  • Pre-market submissions, including PMAs, pre-market notifications (510(k)s), De Novo requests, humanitarian device exemption applications and investigational device exemption applications  
  • Additional information and major deficiency letters  
  • Q-submissions 
  • Informal or interactive inquiries regarding device development  
  • Panel review and recommendations  
  • Post-market surveillance and post-approval studies  
  • Reclassifications and exemptions 
  • Guidance documents and their application  
  • Compliance-related interactions 
  • Regulation development  

According to the FDA, the finalized guidelines will replace "The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles."  

"FDA believes, as a matter of policy, that least burdensome principles should be consistently and widely applied to all activities in the pre-market and post market settings to remove or reduce unnecessary burdens so that patients can have earlier and continued access to high quality, safe, and effective devices," according to the release.