Voices for medical device industry players and consumers clashed in the comments on an FDA proposal announced last November that would limit predicate devices used in 510(k) clearances to those 10 years old or newer.
Opinions between the 42 comments left on the proposal were mostly split between industry representatives and consumers, with industry reps defending the 510(k) pathway as spurring innovation while consumers worried that its oversight is too lax.
Consumer comments on the proposal called for the improvements to or elimination of the 510(k) pathway, citing personal pain, hardship and problems with devices that underwent limited or no human testing, including Johnson & Johnson‘s (NYSE:JNJ) metal-on-metal Pinnacle hip system and surgical mesh devices intended to treat pelvic mesh prolapse that were recently banned by the FDA.
Consumers were not the only commenters in support of the changes, as a small number of healthcare professionals also threw their support behind the proposal, including Samuel Lynch, who claimed they have supported multiple products through both 510(k) and PMA pathways.
“Currently highly invasive 510(k) products can be cleared with little to no real evidence of safety and effectiveness in humans, while PMA products are at the far opposite end of the spectrum requiring years and years of studies costing tens of millions of dollars. Such dichotomy of the FDA review process is unfair to everyone involved, including most importantly patients, healthcare providers and payers who often have no understanding of the different review processes and look at all marketed products as ‘approved by FDA.’ Given the current vast schism between the 510(k) review process and the PMA review process, industry is incentivized to introduce slight variations of ‘me-too’ products with minimal or no advantages to the patient or provider, but which the company can market as the ‘next big thing,’ The current FDA medical device review process, with it egregious chasm between review processes for products that are often not overly dissimiliar, disincentivizes true innovations. Therefore, all steps to raise the bar for clearance of 510(k) devices, and make more sane the requirements for approval of PMA devices, should be implemented. Reducing the gap between the two review and approval processes for medical devices will benefit patients, providers and payers,” Lynch wrote in their comment on the proposal.
Despite facing an increasing amount of scrutiny over the lack of human testing requirements associated with the relatively fast-tracked 510(k) pathway, industry players continued to defend the pathway and claimed that the general public has misconceptions about its validity.
Comments from industry players on the proposal claimed that a limit to 10-year-old devices and newer would be a setback to the system, adding that it could stifle innovation, competition and add more regulatory burden.
Industry comments were especially concerned about the FDA’s proposal of publishing a list of existing devices relying on predicates over 10 years old, going so far as suggesting that such a move may lead to the unnecessary device removals from the market.
Washington-based law firm Hyman, Phelps & McNamara director Jeffrey Shapiro provided pooled data on 200 510(k) clearances from between February 2013 and January 2014 alongside data from 200 more from February 2017 through February 2018 which showed a median predicate age of four years and an average predicate age of six years, according to a Regulatory Affairs Professional report.
“FDA’s proposal to highlight devices with predicates greater than 10 years is not likely to cause great harm. The information is already publicly available in the 510(k) database. FDA did not explain how it will highlight the information, but presumably there will be some sort of notation in the 510(k) database or perhaps there will be a master list posted on FDA’s web site. At the same time, we do not think the proposal is necessary. If a device type has been evolving rapidly, a submitter always has an incentive to choose the most up‑to‑date predicate possible in order to take advantage of FDA’s prior clearances and reduce the data burden,” Shapiro wrote in their comment on the proposal. “That is why our review found a strong natural slant toward more recent clearances. There are some device types that may not evolve rapidly. In these cases, there is nothing pernicious about reaching back to older predicates. It may be somewhat misleading in such cases for FDA to suggest that there is. There is also a certain tension between FDA’s proposal and its claim that the cleared devices met all standards for safety and effectiveness. In our view, the 510(k) system is working quite well in fostering rapid iterative improvement of medical devices. The use of older predicates is not central to the 510(k) system, but it is appropriate in some cases. It does not deserve special opprobrium.”
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