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FDA Priorities: People, Simplicity and a Risk-Based Approach to Speed Time to Market

By John Gagliardi

The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities and bureaucratese. FDA has been accused of going overboard when it comes to clearing or approving medical devices for use in the U.S., and because of the invasive concept of “marketing and selling in a global marketplace,” companies are finding that they can do business in other countries without red tape and inconsistent regulations. For example, FDA-related legal terms and their meanings are sometimes non-uniform, even within the U.S. regulatory system.

Yes, the U.S. remains the largest orthopaedic device market. But my observation is that not all companies are interested in running the FDA regulatory gauntlet—a disturbing trend.

The president of a mid-sized medical device company in Europe recently told me that it wasn’t worth the agita to submit a premarket notification for his Class II devices. So, we didn’t. His company has decided to market in Asia and Europe before they entertain a U.S. clearance. Another medical device client in China is only conducting business in China and Southeast Asia to avoid “unnecessary regulations” and the probability of executing a clinical study on a product that has been in use for 20-plus years.

Ex-U.S. markets are spending money on ex-U.S. medical devices because the world economy is not just made up of the U.S. and Europe. Recognizing this environment, FDA continues to choose strategic priorities to streamline the U.S. regulatory process.

Laying the Groundwork

FDA updates its strategic priorities about every four years to ensure that its plan aligns with its annual performance reporting in congressional budget justifications. It sets forth the agency’s intentions to streamline and improve its operations.

Worldwide, FDA has one of the most laborious regulatory standards for protecting public health. Counter to that, the agency has been historically under-funded, which causes inconsistency when it comes to making changes and addressing the challenges of products manufactured overseas. Because of both high regulatory standards and lack of sufficient funding and program-centric challenges, U.S. citizens have waited up to four or more years for access to lifesaving devices.

Of deceptive importance, there must be robust scientific evidence that a device is safe and effective before approving that product for the U.S. market. Maybe it’s too robust. Maybe FDA has gone overboard. The world marketplace is not viewing the so-called allure of selling products in the U.S. as a necessity to be successful.

FDA chose its strategic priorities over the past five years and for the next four to address this problem. The agency has tried to reduce the time and cost required to bring a product to the U.S. market and support it throughout its life cycle, while not compromising the reasonable assurance of a stringent safety and effectiveness standard.

By advancing a Total Product Life Cycle Approach (TPLC), the user fee program has supported and advanced the agency’s efforts. In doing so, the aim is now toward helping innovators choose the U.S. marketplace, rather than be stymied by a complex and cumbersome regulatory process.Personally, based on my perspective of submitting market clearance documentation, the results are off-center. At the same time, FDA has tried to preserve a top-shelf safety and efficacy standard with the need for rigorous science, upon which American patients rely for quality healthcare. Using flexible, patient-centered benefit/risk models, collaborating more with customers, streamlining internal processes and applying a least-burdensome approach, FDA hopes to be more successful in coming years. 

We’ll see. Promises from 35,000 feet are one thing; feet-on-the-ground reality is a different scene when there is confusion at the top echelon level.

Read more at BONEZONE®. 

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