medical devices that are subject to premarket approval requirements. Plagued with vague concepts such as substantial equivalence, intended use and predicate devices, the program is particularly vulnerable to intermittent inconsistencies in how each concept is interpreted and applied in agency decision-making, as well as misunderstanding by stakeholders that monitor FDA activity. Coupled with the fact that all medical devices are subject to eventual failure, and failure rates are among the most challenging data to understand, demand for regulatory reform is not unexpected. While the US system for regulating devices can certainly be improved, any attempt to reform the 510(k) program should be based on reality, not perception, and a clear understanding of how the components of the entire regulatory system interrelate and contribute to the overall goal of protecting and promoting public health.

In summary, any regulatory framework will have strengths and weaknesses and this applies to the 510(k) program and the rest of the regulatory structure at FDA’s Center for Devices and Radiological Health (CDRH). We show the 510(k) review program’s strengths and weaknesses and suggest important areas for consideration to improve the current system. Should an entire overhaul of the system be attempted, we provide information that may be useful in creating a new regulatory structure and process.

OVERVIEW OF US MEDICAL DEVICE REGULATION

FDA is responsible for protecting the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, biological products, medical devices, foods, cosmetics, and products that emit radiation. The agency is also responsible for promoting the public health by helping to speed innovations that make medicines, medical devices, foods, and radiation-emitting products safer, more effective, and more affordable; and helping the public to obtain accurate, science-based information necessary to use medicines, medical devices, foods, and radiation-emitting products to safeguard their health.1 Recently, FDA was given the authority to regulate tobacco products.

In the context of medical device regulation, the word device is defined by Section 201(h) of the act as follows:


The term “device” (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or

1

Refer to FDA mission statement available at http://www.fda.gov/aboutfda/whatwedo/default.htm.



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