March 11, 1999
Susan Alpert, M.D., Ph.D.
Director, Office of Device Evaluation
Center for Devices and Radiological Health
U.S. Food and Drug Administration (HFZ-400)
9200 Corporate Blvd.
Rockville, MD 20850
Dear Dr. Alpert:
In response to your letter of February 18, 1999 requesting input on how the agency could implement “least burdensome,” our Industry Task Force submits the attached “Least Burdensome Proposal.” As we agreed at the January 4, 1999 meeting, the Health Industry Manufacturers Association (HIMA) established an industry task force consisting of representatives from HIMA, the Medical Device Manufacturers Association, the Association of Medical Diagnostics Manufacturers, Medical Alley, Massachusetts Medical Device Industry Council, National Electrical Manufacturers Association, and the Cook Group (a roster of members is attached).
The attached document represents the collaborative effort of this group. The Task Force believes this document to be a “first step” and would like to meet with you to discuss the proposal in detail and to answer any questions you may have regarding it.
The proposal consists of several sections including a chart describing a hierarchy of increasing burdensomeness, a list of least burdensome general principles followed by examples intended to illustrate these general principles.
We are looking forward to working with you as you develop guidance on implementation of least burdensome and appreciate the opportunity to provide this industry proposal.
James S. Benson
cc: Steve Northrup (MDMA)
Leif Olsen (AMDM)
Thomas Meskan (Medical Alley)
Thomas Sommer (Massachusetts Medical Device Industry Council)
Steven Ferguson (The Cook Group)
Robert Britain (NEMA)