IOM Recommends Scrapping FDA Device Approval Process

July 29, 2011

In an unexpected move, the IOM called for an end to the 510(k) clearance process that has been under revision for the past year and proposed that Congress enact legislation for a new regulatory system after the FDA determines how to create one. The 510(k) process is the current pathway that authorizes low-risk medical devices, including those for imaging.

The Institute of Medicine (IOM) released this morning a recommendation for the FDA to abandon its current process for clearing some medical devices for use.

In an unexpected move, the IOM called for an end to the 510(k) clearance process that has been under revision for the past year and proposed that Congress enact legislation for a new regulatory system after the FDA determines how to create one. The 510(k) process is the current pathway that authorizes low-risk medical devices, including those for imaging.

The FDA published its own new recommendations on Tuesday encouraging medical device manufacturers to submit new 510(k) clearance applications when making a change to previously approved devices. The agency also encouraged manufacturers seeking to avoid a second approval to provide scientific justification for any modifications that wouldn’t affect a device’s safety of efficacy.

According to the IOM report, however, current 510(k) revision attempts aren’t sufficient to protect patients or industry.

“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 IOM committee chair David Challoner, emeritus vice president for health affairs at the University of Florida, Gainesville. “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.”

The agency also requested the FDA either immediately downgrade devices in its 26 high-risk categories or submit them to a more rigorous premarket approval process.

But, for imaging device companies, abandoning 510(k) is not the right choice, said David Fisher, executive director of Medical Imaging & Technology Alliance.

“Manufacturers have been working with the FDA and the broader imaging community to identify and implement targeted and effective improvements to the 510(k) review process,” Fisher said. “It is imperative that this effort continue. The IOM has offered the wrong approach."

The IOM’s assertion that more clinical data is needed to determine a device’s safety and efficacy will present a substantial burden to the imaging community, he said.

“The clinical data the IOM is recommending be gathered will only increase costs and delay new products from being taken to market,” Fisher said. “We know how things like MRIs work and that they’re safe and effective. We won’t learn anything new from clinical trials.”

With its latest guidance, the FDA attempted to provide clear details on when manufacturers would need to resubmit for 510(k) approval. The goal was to make the process easier, according to FDA officials.

“We are making the regulatory process for medical devices less challenging by better describing our expectations,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money.”

However, the guidance also indicates that, even with minimal changes, manufacturers must submit documentation to prove the new product is substantially equivalent to the old one to avoid a repeat 510(k).

This request also presents concerns, Fisher said. The FDA guidance requires manufacturers provide a scientific justification for why modifications should be exempt from a second approval. The definition of scientific justification is currently unclear.

“This might help the [FDA] understand why companies aren’t submitting again for a 510(k),” he said. “But, as an unintended consequence, the agency could become overwhelmed with paperwork and have less time for new 510(k) clearance submissions.”