WASHINGTON — An FDA process for approving some medical devices, in use for the past 35 years, lacks the ability to reliably screen new products for safety and effectiveness prior to their release. The 510(k) clearance process was designed to provide a more expedient way to evaluate moderate-risk Class II medical devices for approval than the premarket approval (PMA) process required for high-risk Class III devices.  The PMA process requires manufacturers to submit results of safety and efficacy tests, while the 501(k) approval process relies only on proof of “substantial equivalence.” This requires only that manufacturers prove that new devices are sufficiently similar to comparable products that were previously cleared or were already on the market prior to 1975 when the 501(k) process was created.

According to a recent report from the Institute of Medicine (IoM), reliance on substantial equivalence cannot assure that devices are safe or effective. Many of the devices used as comparison with new devices have been on the market since before amendments to the law requiring medical-device evaluation. The result is that they were never actually proven to be safe or effective and cannot act as a bar against which to compare new products.

"It's not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help," said David Challoner, chair of the Institutes of Medicine (IoM) committee that generated the report. "The 510(k) process cannot achieve its stated goals — to promote innovation and make safe, effective devices available to patients in a timely manner — because they are fundamentally at odds with the statutes that govern how FDA must implement the process."

Postmarket Oversight

The committee also found substantial weaknesses in current post-market oversight of devices. During its investigation, IoM investigators were told by FDA officials that they lacked the authority to address problems with medical device products already on the market. The IoM report points out that, because no premarket regulatory system is perfect and because industry and patients desire an expedited process for lower-risk products, FDA needs a robust postmarket surveillance program.

As for fostering innovation — one of the stated goals of the 501(k) system — there is no proof that it has done so, the report notes. The process does not require that a moderate-risk device being approved through the system be innovative in any way. And there is no data to suggest whether over the last 35 years the 510(k) system has affected innovation positively or negatively.