Think tank: More FDA 510(k) oversight needed, driving innovation overseas

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“Increasingly burdensome regulatory policy” can be blamed for driving research and development of new medical devices outside the U.S., according to the author of an Oct. 12 Competitive Enterprise Institute essay. The piece called for maintaining the 510(k) process and increasing oversight of the FDA.

In “Stifling Medical Device Innovation,” lawyer and pharmacist Larry R. Pilot argued that the FDA has become overly aggressive, using its regulatory authority to hold back many safe and effective medical devices from reaching the market. The result is drawn-out 510(k) and premarket approval review times that have increased uncertainty about regulatory processes.

While increasing numbers of recalls are enabling criticisms of the device clearance process—some of which call for more onerous requirements, according to Pilot—the violations are often related to statutory or regulatory requirements that don’t affect safety or effectiveness. Pilot noted that, of the recalls issued between 2005 and 2009, approximately 96 percent involved little or no risk of harm to patients.

“Only 131 recalls were considered ‘high-risk,’” wrote Pilot. “Yet even among these, more than half involved infractions such as labeling errors, inadequate instructions or manufacturing glitches that could not have been prevented by a more thorough FDA review.”

Pilot asked why the recent Institute of Medicine report provided no reason to believe that any devices currently on the market are unsafe, yet concluded that the 510(k) process should be scrapped anyway.

“The Medical Device Amendments of 1976 is a good law that has been poorly managed by the FDA. Today, the FDA’s mismanagement is the object of increasing criticism from both supporters and detractors of the 510(k) process,” wrote Pilot. “Criticism by the Government Accountability Office, Institute of Medicine, the FDA itself and others have helped to broaden our understanding of what has gone wrong with device regulation and how it can be improved, but there is no substitute for a fair and balanced independent audit of the FDA’s performance. The time is right for Congress to accept the challenge to carefully examine the structure and management of the FDA and to assure greater accountability.”

Meanwhile, a recent Northwestern University survey of stakeholders in the medical device clearance process found that most favored reform of the 510(k) process, not abandonment.

Pilot’s full article can be found here.