Brent Bankosky Explains How FDA Safety and Innovation Act Can Improve Medical Device Regulation

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The recent Food and Drug Administration Safety and Innovation Act allows for swifter regulation and approval of new medical devices by the FDA. Pharmaceutical expert, Brent Bankosky expands on how this new plan can improve overall healthcare in America.

Last month, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act which was created in order to build more efficient regulation procedures of new medical devices and medicines in America. A recent article in Forbes provides further details on the reasons for the new act and how it will effect current healthcare regulation. It states, “The [Innovation Act] includes the third authorization of user fees, paid by the medical-device industry to the FDA, so that the FDA can improve its performance in licensing new medical devices.” Brent Bankosky, a corporate strategist working in pharmaceutical industry, notes that the new legislation will not only improve medical device safety, but also deliver much-needed improvements in productivity among FDA staff members.

According to the article, the U.S. already has a great track record regarding the safety of new medical devices; however, the time it takes to get these potentially beneficial products to the consumer market is lengthy. Following the instituted 510(k) process, the FDA has adhered to strict regulation of new medication and devices, resulting in “over 99.5 percent of both 510(k) submissions and PMA submissions during [a 2005-2009] period did not result in a recall.” Still patients and producers seek quicker implementation of approval, something that Brent Bankosky believes will be possible under the guidelines set forth under the Innovation Act.

Through Bankosky’s observation, he states that user-fees are not all that new, and have already proven effective in the industry. He explains, “The medical device industry began paying user-fees in 2003 with mixed results despite the increase in funding for medical device regulation. Initially, the number of FDA 510(k) and PMA submissions dropped substantially. More recently, the performance of the FDA appears to be improving as the number of FDA 510(k) submissions and PMA submissions has increased along with a continued strong track record of safety as evidenced by the 0.5 percent recall rate between 2005 and 2009.”

Instead, Brent Bankosky believes the success of the innovation will be determined by the improvements made in the FDA’s internal procedures. Bankosky concludes, “Staff productivity at the FDA continues to be an area of concern and should improve with the signing of the FDA Safety and Innovation Act due at least in part to stricter timelines and a better classification process.”

ABOUT:

Brent Bankosky is a business executive and corporate strategist who has a strong background in the pharmaceutical industry. Through his work, he has assisted multiple pharmaceutical companies. Additionally, Brent Bankosky has accrued global experience, allowing him to understand the international implications of innovations within the pharmaceutical industry, as well as to work well with professionals from a variety of backgrounds and cultures.

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Michael McGarety
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