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U.S. Department of Health and Human Services

Medical Devices

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The Least Burdensome Provisions - Activities Related to Implementation

 The Federal Food, Drug, and Cosmetic Act as Amended by FDAMA of 1997

FDAMA added the following two provisions to the Federal Food, Drug, and Cosmetic Act. These two provisions are commonly referred to as the "Least Burdensome Provisions."

Section 513(a)(3)(D)(ii)

"Any clinical data, including one or more well-controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of a determination by the Secretary that such data are necessary to establish device effectiveness. The Secretary shall consider, in consultation with the applicant, the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval."

Section 513(i)(1)(D)

"Whenever the Secretary requests information to demonstrate that devices with differing technological characteristics are substantially equivalent, the Secretary shall only request information that is necessary to making substantial equivalence determinations. In making such requests, the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and request information accordingly."
Posted Least Burdensome Final Guidance
  IDE and PMA Documents  
  • "Pre-IDE Program: Issues and Answers" (Blue Book #D99-1)
  510(k) Documents  
  Lessening Regulatory Burden - Related Documents  
  • After November 1, 2000, all letters in which additional information is requested for pending 510(k)s, PMAs, IDEs, and HDEs will contain boilerplate Least Burdensome language. This language will indicate  that the Agency considered the least burdensome approach  to resolving the outstanding issues associated with the application. Similar language will also  appear in all CDRH final guidance documents issued after the above date. The following is an example of the least burdensome language as it will appear in the 510(k) letters in which additional information is requested
  CDRH/Industry Collaborative Efforts   
  Training Materials  
  • Staff Update: The Least Burdensome Provisions of FDAMA- April 4, 2000 - An overview of the least burdensome provisions and an update on CDRH progress in implementing these changes in the statute.
  • Least Burdensome training for the CDRH’s Advisory Panels 
  • Least Burdensome training for CDRH staff