Researchers Call on FDA to Tighten Requirements for Breakthrough Devices

Regulatory NewsRegulatory News
| 29 August 2018 | By Michael Mezher 

A team of researchers are calling on the US Food and Drug Administration (FDA) to require more evidence and impose stricter limits on medical devices approved through the agency's new breakthrough devices program.

The call comes in a research letter published this week in JAMA Internal Medicine by researchers at the University of California, San Francisco and Yale University that found a high number of recalls for high-risk cardiovascular devices approved under FDA's priority review program.


FDA's breakthrough devices program was created under the 21st Century Cures Act and supersedes and combines several of the agency's existing programs to speed access to innovative new devices including priority review and increased communication with agency staff.

In October 2017, FDA released a draft guidance detailing the features of the breakthrough devices program, which explains that the agency "may accept a greater degree of uncertainty of the benefit-risk profile for these devices if the uncertainty is sufficiently balanced by other factors … and adequate postmarket controls to support premarket approval."

Priority Devices

To conduct their analysis, the authors reviewed the pivotal studies and other factors, such as whether the devices were subject to an advisory committee prior to approval or if they were recalled (Class I or Class II), for all high-risk cardiovascular devices granted premarket approval via priority review from 2007-2017.

Nearly half (14/29) of the devices approved under priority review during that time were cardiovascular devices that were studied in a total of 18 pivotal trials. Only half of the studies were randomized, none were double-blind and only three were single-blind.

"We found that most FDA priority review approvals for the cardiovascular devices were granted on the basis of a single nonrandomized, nonblinded pivotal study that used surrogate endpoints," the authors write.

FDA also required advisory committee reviews of 10 of the devices. Of the nine committees that voted on safety and effectiveness, four votes found that there was not a reasonable assurance that the device was effective, though all were found to be safe.

Six of the 14 devices have been subject to a recall after gaining approval, with a total of two Class I and 13 Class II recalls for those six devices.

Because most cardiovascular devices approved under priority review are permanently implanted, the authors say the devices "risks and benefits should be well understood before clinical use" and should be supported by larger studies with longer follow up times.

In most cases, FDA has required postapproval studies for devices approved via priority review. However, such studies can take years to complete and are often delayed, leading to a gap between approval and the availability of more robust evidence to support the devices' use.

"To ensure that device manufacturers are completing postmarketing studies and acting on the resulting data, the FDA should issue time-limited approvals with mandated periodic re-review of the device's safety and effectiveness," the authors write.

Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program


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