The medical device industry is criticizing a US Food and Drug Administration (FDA) proposal to limit the use of older predicate devices, citing misconceptions about the 510(k) pathway, hindered market access, stifled innovation and competition and more regulatory burdens.
The comments on the November 2018 proposal
argue that a limit on manufacturers’ use of predicates would be a setback from improvements made to the program since its 1976 enactment.
The 510(k) pathway—through which low- to moderate-risk medical devices can seek FDA market clearance by demonstrating substantial equivalence to predicate devices—has been the most commonly used premarket review pathway for decades. It recently came under scrutiny after reports, such as Netflix’s The Bleeding Edge, depicted it as a “regulatory loophole.” But industry maintains that the 510(k) pathway is safe and effective.
“The 510(k) regulatory process has been, and remains, a successful program that ensures the safety and effectiveness of medical technology while encouraging device development and facilitating the availability of high-quality medical devices to improve patient care and meet the needs of clinicians and the American public,” said AdvaMed vice president of technology and regulatory affairs Ruey Dempsey.
A common theme across commenters on the proposal is: There appears to be no public health reason to support limiting the use of predicates to those that are 10 years old or less, nor does there seem to be a reason to make older ones ineligible for use in demonstrating substantial equivalence to existing medical devices.
The argument against implementing the proposal is centered on the age of the predicate device being an arbitrary exclusion criterion. Predicates are used to classify devices, but 510(k)s include data on performance and testing to support substantial equivalence determinations. Manufacturers also tend to leverage other methods to maintain a product’s risk-benefit profile, such as risk management systems and standards.
The part of the proposal on whether FDA should make public a list of existing devices that rely on older predicates is seen as particularly concerning for industry, with commenters taking issue with the agency implying that older predicates are not as safe and effective as newer predicates.
“Mere passage of time is not an appropriate determiner of scientific and/or clinical relevance,” said Dempsey. “AdvaMed believes that publishing such a list will not drive anyone to develop devices with newer technology and may actually lead to well-established devices being unnecessarily removed from the market.”
The absence of a device in the proposed list solely based on the predicate’s age could further imply a change in a benefit-risk profile that renders a device unacceptable, compromising patient access. Commenters say that these implications can perpetuate misunderstandings about use of the 510(k) pathway, create new false perceptions, hinder access to quality devices as well as stifle innovation efforts and market competition.
AdvaMed also points to established devices, including sutures, spinal screws and in vitro
diagnostic (IVD) products, for which “the foundational technology has not changed in many years” as another reason to not disqualify predicate devices just because of their age and suggest that such products are “inferior.”
A limit on the use of predicates could also restrict growth in the Special 510(k) program, which manufacturers can use to propose changes to existing devices and bypass certain requirements for expedited clearances.
Another aspect of the proposal seeks feedback on whether there is a need for FDA to pursue additional authority
to make some older predicates ineligible. This is despite CDRH reportedly
eliminating the use of 1,758 devices as predicates—1,477 (84%) of which were cut since 2012.
Jeffrey Shapiro, director at Washington-based law firm Hyman, Phelps & McNamara, pooled data on 200 510(k) clearances between February 2013 and January 2014 and 200 more from February 2017 through February 2018 that indicate a median predicate age of four years and an average predicate age of six years.
“FDA’s proposal to highlight devices with predicates greater than 10 years is not likely to cause great harm” but “we do not think the proposal is necessary,” said Shapiro. He attributed “a strong natural slant” to the incentive a submitter has to choose the most up-to-date predicate to leverage prior 510(k) clearances and reduce data burden if a device type has been rapidly evolving.
If the agency does decide to go ahead with implementing the proposal, AdvaMed suggested that FDA identify objective evidence that limiting the use of older predicates would improve the 510(k) program.
The Consumer Healthcare Products Association also advised on what not to include in the proposed list of predicates, including well-established technologies without a need for improvements.