The medical device industry is a textbook story of manufacturing success in the United States. This industry, comprising manufacturers of devices and diagnostics, is a sector of the manufacturing where the U.S. leads the world. Medical technology represents the 11th largest manufacturing sector in terms of exports and has consistently maintained a favorable balance of trade. Yet, actions being considered by the Food and Drug Administration with respect to the approval of devices threaten to stifle innovation and cost Americans jobs.
The FDA is considering making changes to the 510(k) approval process, which in its current form, demonstrates an exemplary record of safety and effectiveness. (Federal Register notice.) However, despite significant increases in resources made available to the FDA through user fees and appropriations enacted as part of the Medical Device User Fee Act in 2002 and reauthorized in 2007, performance at the agency has markedly declined since 2003. For example, total review times, number of review cycles, amount of time manufacturers spend answering FDA questions after products are submitted for review or the withdrawal of applications before a final decision have gone up – even with the additional resources afforded the FDA. So what’s the answer from the agency? Notwithstanding an outstanding safety record, they want to make it more difficult and time consuming to get new products to patients.
The proposal under review at the FDA would do the following:
- Impose arbitrary limits on acceptable predicate devices
- Redefine the term “substantial equivalence”
- Eliminate separate classification of intended use and indications for use
As the National Association of Manufacturers argues in a joint comment letter with the U.S. Chamber of Commerce, making these changes will increase approval time and costs with no appreciable benefit to consumer safety or device effectiveness. Indeed, such changes could negatively affect public health by curtailing the availability of needed treatments and cures. The FDA should carefully reconsider these proposals and err on the side of doing no harm to a process and an industry to which many Americans owe their lives and livelihood.
Joe Trauger is vice president of human resources policy at the National Association of Manufacturers (NAM).
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