Industry Provides Mixed Reaction to ‘Modernized’ 510(k) Premarket Clearance Program


Posted July 18, 2018

The Food and Drug Administration’s (FDA) proposal to "modernize" its approach to clearing moderate-risk devices by establishing an expanded version of the Abbreviated 510(k) program was met with a wide array of responses during its commenting period, which ended July 11. Some groups lauded the agency’s effort to streamline the clearance of some medical devices, while others expressed concerns over the plan’s implementation and potential effects on patient safety.

The proposed Expanded Abbreviated 510(k) premarket clearance program, outlined in an April draft guidance document, would allow medical device manufacturers to compare the performance of some medical devices to FDA-identified criteria rather than measuring them directly against previous device designs, called predicate devices. Such an approach would offer “a more efficient and less burdensome option to demonstrate that certain new devices are substantially equivalent to ones already on the market” and improve access to iterative device designs, FDA Commissioner Scott Gottlieb said in a statement.

In comments submitted to the FDA, Ruey C. Dempsey, vice president of technology and regulatory affairs at AdvaMed, said the Expanded Abbreviated 510(k) program could complement current pathways that have “served patients and the industry well” by “assur[ing] that patients have timely access to safe, effective, and high-quality devices.” However, he expressed concern that “the Expanded Abbreviated 510(k) [program] depends on guidance documents written by FDA for each device type, which will define the performance criteria for each device type.”

Dempsey urged the FDA to provide more information about how those future guidance documents will be prepared and involve stakeholders in the process.

“The draft guidance states that source criteria will come from FDA staff, information in literature, and analyses of data for existing devices. Absent from the list is input from healthcare professionals and other relevant stakeholders, including industry, which is typically gathered during the comment period for a draft guidance,” Dempsey wrote. “Consulting with healthcare professionals and other stakeholders offers perspectives and expertise different from sources that FDA proposes to reference. Consequently, to assure that FDA applies all relevant information, these parties require an opportunity to review and comment on device type performance criteria.”

America’s Health Insurance Plans (AHIP), a national advocacy and trade association for the health insurance industry, also expressed concern that the proposed program relies on materials that the FDA has said are forthcoming. Such a program is difficult to evaluate, according to Richard A. Bankowitz, AHIP’s chief medical officer, because a list of eligible devices is not yet available.

The FDA said in its draft guidance that it intends to maintain a list of eligible devices and provide information about applicable performance criteria, testing methods, and other relevant information on its website. Bankowitz also warned in his comments that an expansion of the abbreviated premarket clearance pathway would exacerbate potential safety issues that already exist in the standard 510(k) premarket clearance process.

“Given that complex medical devices are currently entering the market through the 510(k) process without a comprehensive clinical evaluation of their safety and effectiveness, we do not believe the existing process strikes the most appropriate balance between innovation and safety,” Bankowitz wrote. “Accordingly, we are even more concerned with the draft guidance’s proposal to expand the abbreviated 510(k) program and allow a greater number of devices to demonstrate substantial equivalence through performance criteria rather than head-to-head comparisons with predicate devices.”

On the other hand, the American Medical Association (AMA) was generally supportive of the proposed Expanded Abbreviated 510(k) program in its comments, noting that such a program would help manage the rapid, iterative improvements being made in medical devices and would better utilize FDA’s finite resources to evaluate them.

“In light of rapid iterative improvements in the device area and expanding portfolio of devices that are and will be subject to FDA oversight, the AMA supports efforts to identify device manufacturers that consistently produce high-quality devices and then focus resources on helping other manufacturers raise their level of quality,” wrote James L. Madara, AMA CEO and executive vice president. “The AMA believes that the proposed Expanded Abbreviated 510(k) [program] provides an important oversight pathway to those manufacturers that are committed to quality.”

However, Madara emphasized that his organization’s support relies on the FDA allocating “adequate resources and funding” to the program’s provisions so the agency can review underlying performance data when necessary.