FDA Doubles Down on Medical Device Program

FDA has been establishing policies to benefit new programs for the medical device industry, including opportunities in the Digital Health arena and promoting the use of Real World Evidence. 

Though advancement in these next-generation concepts tend to garner more fanfare, readers shouldn’t overlook the modifications being made to FDA’s “bread-and-butter” medical device pathways. These more fundamental changes will likely have a larger impact on the medical device industry as a whole than their next-generation counterparts that attract a flurry of mainstream attention.

Last month, FDA announced its intent to overhaul the 510(k) program – by far the most common regulatory pathway for the premarket review of medical devices. Devices cleared through the 510(k) program must be substantially equivalent to “predicate” devices that are already marketed. Framed as a step toward modernization, the agency announced it is contemplating sunsetting predicates that are more than 10 years old so that devices cleared through the 510(k) pathway better reflect current technologies. It’s questionable whether FDA has the statutory authority to sunset older predicates. FDA more likely requires a statutory “fix” from Congress to implement this concept. Such “fix” would also likely require notice-and-comment procedures to specify which device types would sunset since it’s unlikely for a statutory revision to dictate that all device types would automatically become ineligible as predicates after 10 years. In addition to the potential sunsetting of predicates, FDA has taken other regulatory steps to modernize the 510(k) program to reflect newer technologies. In April 2018, FDA issued the Draft Guidance, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. That guidance document proposed that in lieu of comparing Class II devices to predicates, manufacturers of certain devices would have the option to use objective performance criteria as a basis for comparison. In a statement issued in tandem with the guidance, FDA signaled that the potential ability to use objective performance criteria as a comparator shared the same intent as the potential sunsetting of predicates - specifically, “predicate devices are sometimes decades old.” While acknowledging it does not believe older predicates are unsafe, the Agency also asserted that “some devices are not continually improving.” Potentially closing the door to older predicates and simultaneously opening the door to objective performance criteria illustrates FDA’s desire to usher device technologies along a prescribed pathway the agency believes will benefit the public health.

Less than two weeks after FDA announced its plan to sunset older predicates, FDA issued a proposed rule for the De Novo pathway. De Novo submissions are a major focus for the Agency because of the innovative technologies they concern. Essentially, De Novo submissions allow for the classification of novel devices that do not present enough risk to remain in the default Class III, under which a premarket approval application (PMA) would otherwise be required. The Agency evaluates the benefits and risks of a device reviewed under a De Novo submission to determine whether it can be regulated in the lower risk categories of Class I or, more commonly, Class II. Because a condition for FDA to grant a De Novo is that that there is no valid predicate available (i.e., marketed device that is substantially equivalent to the subject device), devices marketed through the De Novo process are, by their very nature, unlike existing devices. Recognizing the public health potential of these innovative devices, FDA began tracking the agency’s performance of review of De Novo submissions, an initiative that came at a cost to industry in the form of user fees, but nevertheless has greatly improved review timeframes. Submission of De Novo applications and subsequent interactions with the Agency was largely instructed by FDA’s De Novo Guidance that was issued in October 2017. The Guidance, however, derived its authority directly from the Federal Food, Drug, and Cosmetic Act whereas, typically, statutes are implemented through regulations, which are then interpreted through guidance. Given that a guidance is generally reliant on its parent regulations, finalization of the De Novo proposed rule may prompt revisions to FDA’s guidance on the topic. Two particularly controversial, and potentially burdensome, aspects of the proposed rule that were not addressed in the pre-existing De Novo guidance are a requirement for submissions to include advertisements for the device and the ability for FDA to inspect manufacturing facilities prior to granting a De Novo submission. We expect extensive feedback to be submitted on these issues before the March 7, 2019 comment period deadline.

The Agency followed up its regulatory activity regarding the 510(k) and De Novo programs with a December final rule relating to medical device classification procedures. The final rule codifies authority granted to FDA by the Food and Drug Administration Safety and Innovation Act of 2012. Under that legislation, FDA was provided the ability to reclassify certain device types through administrative order rather than rulemaking. Though both processes require the Agency to consider public comment, administrative orders have not been interpreted to require economic impact analyses. This distinction may seem trivial but analyzing economic impacts of a mandate can be a rate-limiting step to rulemaking, particularly since it may be established only once the terms of the rule are settled. Forgoing this procedural step allows the Agency to more quickly reclassify certain devices. FDA has already gained considerable experience with the administrative order process through its 515 Program Initiative, under which the agency reclassified or called for PMAs for preamendments Class III devices that were being marketed via 510(k) submissions. Through the administrative order process, the final rule may also permit the agency to more quickly institute postmarket regulatory actions in response to a safety concern. FDA’s Medical Device Safety Action Plan indicated that the agency was exploring how to more rapidly impose special controls when warranted based on new information. One can envision circumstances in which rather than applying special controls to address a serious postmarket safety concern, the agency proceeds directly to upclassify the device type – a regulatory action potentially accelerated by this rule.

Fundamental changes to the 510(k) pathway, De Novo pathway, and reclassification procedures are expected to re-shape the medical device regulatory landscape for years to come. Readers are encouraged to carefully consider how their products may be affected by the continuous regulatory transformation and develop strategies to, as FDA puts it, “skate to where the puck will be.”


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