FDA Looking for More Authority

At a meeting of the FDA and the medical device industry, the FDA noted that its limited powers, such as in regulating products already on the market, in controlling how manufacturers label their products and even tracking devices when their manufacturers sell their business, may lead the agency to seek broader powers from Congress (see WSJ). Industry representatives attending, including Medtronic, as well as noted industry law firm Hogan & Hartson, pressed the case for caution in any changes to the approval process particularly the 510(k) “substantially equivalent”, expedited approval process. Although the industry recognizes the need for reforms in the process, it fears any changes may raise the barrier and unduly slow the approval of qualified devices as well as put an overall damper on industry investment.

No specific timeline, nor specific likely changes, have been laid out by the agency, which thus far has garnered some credit among the medical device industry for its participatory process with industry.

Leave a Reply