Originally Published IVD Technology
July 2003
EDITOR'S PAGE
Taking action and speaking loudly
Ever since the Center for Devices and Radiological Health established the Office
of In Vitro Diagnostic Device Evaluation and Safety (OIVD), IVD manufacturers have been raising a number of questions and concerns about the effect this new office will have on them and the industry as a whole. Will the new office streamline the review process? Will it be more rigorous about enforcing regulations? Will it push for more-stringent requirements, thereby making approval even more difficult to attain?
During the past several months, OIVD’s director, Steven Gutman, MD, has made an effort to spread the word about the new office and its intentions.
He has spoken about OIVD at numerous industry meetings and conferences and in various interviews (including an interview published in IVD Technology’s June 2003 issue). At the annual meeting of the Association of Medical Diagnostics Manufacturers (Washington, DC), Gutman spoke about OIVD’s intention to break down the barriers to regulating IVDs by having faster response times and a more dynamic organization. At the same time, he discussed compliance issues and stated that the new office plans to start working on any such problems within 48 hours.
However, the fact remains that actions speak louder than words. One recent action speaks very loudly of OIVD’s intention to take an even more active role in regulating the IVD industry. The office issued its first warning letter to a company for inappropriately claiming that one of its devices is for research purposes only (see News, page 13). This letter is an indication that OIVD is going to follow through on its stated plans of taking an active role in not only premarket but also postmarket activities, as dictated by its total product life-cycle approach to regulating
IVDs.
Despite the action that OIVD took by issuing this warning letter, the verdict is still out as to whether the new office will succeed in making this transition to this total product life-cycle approach. The purpose of forming OIVD was not simply to give a new name to the former Division of Clinical Laboratory Devices, which dealt only with premarket matters. In addition to premarket activities, this new office plans to get heavily involved as well in all postmarket activities. This is what total product life cycle is all about. So the bottom line is that total product life cycle is here to stay,
and the IVD industry had better start getting used to it.
Richard Park
richard.park@cancom.com
Copyright ©2003 IVD Technology
