Medical Device Regulation

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An important element of the ongoing healthcare debate is the regulation of medical devices. To date, there has been much ambiguity in regards to the Administration’s intentions. The Institute of Medicine has completed a review of certain FDA regulation procedures, but questions remain over the utility of the study.

In another recent study of the 510(K) approval pathway, three-quarters of the respondents rated clarity of 510(K) submission requirements as “somewhat unclear/uncertain” or “very unclear/uncertain” and almost half of the respondents indicated that their decision to market their devices outside of the U.S. was based on uncertainty in the 510(K) process.

The medical device sector is comprised of over 8,000 companies in the U.S. Between them, they generated about $136 billion in sales and employ over 422,000 Americans. The industry is dominated by innovative small companies with less than 20 employees. If regulatory uncertainty continues, it could seriously undermine the health of the market for medical devices. In the healthcare sector this can have repercussions beyond decreased growth and job loss.

Medical device innovation is essential to improved health outcomes and can significantly reduce cost. At their best, these devices allow the early detection, continuous monitoring, and treatment of chronic diseases and turn complicated and costly surgeries into outpatient procedures. The increasing complexity of new technology has created a number of gray areas that have complicated the approval process.

For example, a new host of wireless medical solutions in the medical device field have created significant confusion regarding where these devices stand in terms of regulatory obligations. Currently, both the FCC and FDA need to be working in concert to develop a regulatory solution. In an article for GovernmentHealthIT, Ed Cantwell, Senior Vice President of West Wireless said,

“ Wireless technologies present a complex ecosystem that requires the FCC and FDA to be involved. We need to bring this ecosystem together to tame the wild wild West that is wireless in the healthcare environment.”

In examining this industry, regulators must balance enhancing patient safety with increasing the availability of life-saving and innovative medical device products. As FDA and other partners examines alternative regulatory approaches, it is crucial to consult a broad spectrum of stakeholders within the industry and the medical profession to ensure that there are no unintended consequences. Vital issues such as this call for nothing less.

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