Originally Published IVD Technology
May 2004
EDITOR'S PAGE
Staying informed and getting involved
At the recent annual meeting of the Association of Medical Diagnostics Manufacturers (AMDM; Washington, DC), several speakers talked about the major regulatory issues that could affect the IVD industry in the future. Jonathan Kahan, a partner in the law firm of Hogan & Hartson (Washington, DC), said the analyte specific reagents (ASRs) issue is creating “a revolution in the middle of the IVD industry.” Kahan added that FDA should clarify the ASR regulations.
In another presentation, Glen Freiberg, vice president of regulatory, quality, and government affairs at Gen-Probe Inc. (San Diego), discussed the recent proposal for a new regulatory category: in vitro analytical tests (IVAT). Freiberg said that even though FDA initially balked on adopting the IVAT proposal, the agency could still turn around and adopt it.
These speakers encouraged IVD manufacturers to take an active role in shaping regulatory issues. FDA is continuing to examine such regulatory issues as ASRs and the IVAT proposal and exploring ways to implement solutions for them. FDA’s policy decisions regarding such issues could affect IVD manufacturers and the way they do business.
Consequently, IVD manufacturers should stay informed about regulatory issues that affect them, and look for ways to influence FDA’s decision-making process regarding such issues. IVD manufacturers should be involved in shaping the issues to ensure that the regulations reflect their needs and do not hinder their business.
IVD manufacturers should take advantage of opportunities to influence regulatory policies. Officials at the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) are not mind readers. So it is important for IVD manufacturers to give their input about improving proposed rules and guidances.
Industry involvement can have a dramatic effect on the shape of regulations. For example,
AdvaMed (Washington, DC) vigorously lobbied and worked with FDA on a proposed standard for the use of symbols on IVD labels. After four years, the agency released last fall a draft guidance on using symbols on
IVDs.
At the AMDM meeting, Donald St. Pierre, deputy director for new device evaluation at OIVD, admitted that “if IVD manufacturers and AdvaMed had not pushed the symbol issue as hard as they did, it probably would not have gotten through.”
By being more informed about and involved in regulatory issues, IVD manufacturers will be able to influence the regulations that affect their businesses and the industry as a whole.
Richard Park
Copyright ©2004 IVD Technology
