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Study: Insufficient Oversight on Modifying FDA-Approved Devices

Study: Insufficient Oversight on Modifying FDA-Approved Devices

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Action Points

  • Manufacturers of dermatologic devices are increasingly gaining approval for device modifications via post-initial approval pathways requiring minimal supporting clinical data, which could influence device effectiveness and safety.
  • Note that these data suggest that greater transparency and higher standards of review may improve inconsistencies in usage of pathways for device approvals, and this will allow better assessment of the safety of device modifications.

Dermatologic device makers often slip substantial product changes through FDA clearance by taking advantage of loose premarket approval (PMA) supplement applications, researchers said.

A search through the FDA online PMA database showed that for the 27 Class III dermatologic devices approved between 1980 and 2016 through the PMA pathway, 562 PMA supplements were green-lighted. On the whole, device makers ramped up their use of these supplemental applications over time: in 1980-1989, supplements were approved at 3.7 per year, whereas the 2006-2015 period saw 36.7 supplements approved per year (an 891.9% increase), according to the study published online in JAMA Dermatology.

“This indicates a higher rate of supplements per device-year in dermatology than other reported specialties, including orthopedics, otolaryngology, and cardiology,” said investigators led by Harib Ezaldein, MD, of University Hospitals Cleveland Medical Center. The 27 dermatologic devices that had approved changes were 14 injectables, 11 photodynamic therapies, one dermal replacement matrix, and one diagnostic imaging instrument.

The worry is that dermatology device changes may not be sufficiently backed by clinical data in many cases, the team suggested, noting that the 30-day supplement track that does not require clinical data (meant only for adjustments to a device’s manufacturing process) accounted for 42.5% of supplemental PMA approvals.

Meanwhile, it appeared that the rigorous panel-track pathway was much less popular, coming in at just 2.8% of PMA supplement approvals. This track requires clinical data and is intended for significant changes such as those in device design or performance, or a new indication for use.

It is therefore problematic that another track, the 180-day process, was used for 41.7% of label indication changes instead of the aforementioned comprehensive panel track requiring clinical data and a formal review process. “As manufacturers make increasing use of supplemental applications, minor device changes may occur without supporting clinical data, which could pose a safety risk to patients,” Ezaldein and colleagues wrote.

Indeed, safety issues came up eventually in many cases, with 14.8% of dermatologic devices undergoing low-risk recalls (Class II or III) and 37.0% voluntarily withdrawn by the manufacturer. For example, both injectable products from Merz were recalled after undergoing 135- and 30-day applications).

“The current regulatory environment does not provide sufficient information necessary for dermatologists to make informed clinical judgment regarding potential device problems,” the researchers emphasized. “There is a dearth of FDA review memos in dermatology, which are normally published to disclose information about modifications. Increasing disclosure about device modifications across all supplementary pathways may promote more reliable safety in Class III dermatologic devices.”

Caveats to the study include the exclusion of devices approved through the cheaper and less robust 510(k) pathway, the authors acknowledged.

Nonetheless, they suggested that to make devices safer for patients, an advisory board tasked with reviewing a product for clinically significant device drift after a defined number of years or PMA supplement applications should be created.

Employees of the FDA responded in an accompanying editorial that the agency is in fact making efforts to improve how it assesses medical device safety: In building the National Evaluation System for Health Technology (NEST), it “will link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records, and medical billing claims,” wrote Laura Marquart, MD, and colleagues from the FDA Center for Devices and Radiological Health in Silver Spring, MD.

“The FDA anticipates exponential growth in knowledge about actual clinical use of specific devices through NEST, which will more efficiently generate evidence for, and decrease the time and cost of, medical device evaluation,” the editorial continued. “Concurrently, the FDA is seeking ways to enhance the robustness of available clinical evidence through the development and coordination of registries.”

Both Ezaldein and co-authors and Marquart and co-authors reported having no relevant conflicts of interest.

2018-01-25T13:00:00-0500

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