Medical Devices

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."

PostedLeast Burdensome Final Guidance
9/30/2002The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry
 IDE and PMA Documents
5/29/2001Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
9/9/2000Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997
7/12/1995"Goals and Initiatives for the IDE Program" (Blue Book #D95-1)
3/25/1999"Pre-IDE Program: Issues and Answers" (Blue Book #D99-1)
2/28/2001"Early Collaboration Meetings under the FDA Modernization Act (FDAMA)" Final Guidance for Industry and for CDRH Staff
 510(k) Documents
5/28/2002Invitation to Preparers of Abbreviated 510(k)s for Selected Devices re: Summary Reports
11/16/2001"Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA" - This guidance updates review procedures to bring consistency with Least Burdensome concepts and ODE procedures.
3/12/2000"Guidance for Industry and for FDA Staff – Use of Standards in Substantial Equivalence Determinations"
2/19/1998"Guidance for Industry and CDRH Staff -- New Section 513(f)(2) – Evaluation of Automatic Class III Designation" (Blue Book #G98-1)
3/20/1998"The New 510(k) Paradigm –Alternative Approaches to Demonstrating Substantial Equivalence in Premarket Notifications"
10/22/1998"Frequently Asked Questions and Answers on the New 510(k) Paradigm"
 Lessening Regulatory Burden - Related Documents
5/3/2001The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Draft Guidance for FDA and Industry (Issued on May 3, 2001)
11/2/2000Guidance for Industry and FDA Staff: Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA. (Issued on November 2, 2000)
9/11/2000Guidance for Industry: A Suggested Approach to Resolving Least Burdensome Issues (Issued on September 11, 2000
 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
7/17/2000"A Systems Approach to Premarket Review"
11/15/2001Special Controls Guidance Documents to Reduce Regulatory Burden
 CDRH/Industry Collaborative Efforts
3/20/2000"The Least Burdensome Provisions of the FDA Modernization Act of 1997 – Concept and Principles" – a Document Prepared by Representatives of the Least Burdensome Industry Task Force and FDA
 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

Page Last Updated: 10/30/2014
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