Medical Device Industry Skeptical of Review Process, According to New Survey

By Mike Rozembajgier

Here on ExpertINSIGHTS recently we have discussed concerns about the Food and Drug Administration’s 510(k) approval process, including reports that since 2005 fully 70 percent of recalled medical devices had been approved through this fast track process. Not surprisingly, the process has come under fire from safety advocates, academics, and lawmakers alike. In light of this growing criticism, medical device manufacturers should be ready to provide convincing documentation that their devices are safe. And there is no time like the present to prepare your recall management team and test your recall plan just in case yiou do need to initiate a recall.

According to an industry-wide survey conducted by Northwestern University, only eight percent of respondents believe that the 510(k) review process for medical devices sold in the U.S., is the most predictable regulatory system available. Two-thirds cited the European system as the most predictable. As a result, many are now seeking European clearance for their products before trying to enter the U.S. market.

This is hardly surprising given that some 98 percent of those surveyed consider the predictability of regulatory requirements to be a critical factor in deciding where to invest in new product development. In a recent InHealth press release detailing the Northwestern survey, lead project researcher John Linehan, PhD, notes that “as the FDA considers regulatory revisions, what’s at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace.”

The Northwestern survey clearly shows that unclear guidelines, inconsistent implementation, and regulatory unpredictability are resulting in a lack of trust and a weakened regulatory system in the U.S. According to the survey, there is a growing crisis of confidence in the FDA’s overall ability to properly regulate the medical device industry.

The 510(k) process, which requires a manufacturer to provide only minimal data on safety and effectiveness in order to receive approval to manufacture and sell a device, has been positioned by some as the leading cause of this lack of confidence in the FDA. The many problems cited by industry professionals suggest that changes in the 510(k) process are necessary if the U.S. is to remain a key driver of innovation and bearer of high quality safety standards in high tech industries, such as medical devices.

All this is just another indication that the regulatory environment for consumer products of all kinds – from pharmaceuticals and medical devices to food and consumer products – is changing. Regulators, manufacturers and retailers alike are under increasing scrutiny from nervous regulators and concerned lawmakers looking to protect their constituents. In such an unpredictable regulatory environment, you would be wise to keep a close eye on changing regulations and prepare for the worst-case scenario.

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