FDA Finalizes Guidance on New Marketing Pathway for Medical Devices

FDA recently issued a guidance document that intends to reshape the agency’s cornerstone medical device program – the 510(k) pathway. Traditionally, devices commercialized through the 510(k) pathway would need to demonstrate substantial equivalence to a similar legally marketed device, i.e., a “predicate device.”

As we reported last year, the agency telegraphed its intent to provide a new option for manufacturers to leverage objective performance criteria in lieu of predicates and last week, the agency made good on its pledge. Through the Safety and Performance Based Pathway Final Guidance, manufacturers are one step closer to receiving from FDA a device-specific blueprint to market their device using a predetermined technical benchmark. The natural upside, as the agency stated in the guidance, is that “it may be more burdensome for a submitter to conduct testing against an appropriate predicate device to demonstrate equivalence for the necessary set of performance and technological characteristics than to demonstrate their device meets appropriate performance criteria established by FDA.” Additionally, taking advantage of objective performance criteria could reduce FDA review time of the application since the agency would have familiarity with comparisons to the criteria. The particular device types to which the Safety and Performance Based Pathway will be available have yet to be identified, subsequent to which FDA intends to issue device-specific guidance announcing the applicable objective performance criteria.

In the meantime, however, it’s important to consider the potential downstream implications of the initiative. From a competitive perspective, manufacturers that utilize the Safety and Performance Based Pathway may struggle to find ways to differentiate their devices from other devices that are equivalent to the same criteria. This concept prompts broader questions related to public health and FDA’s mission - will the push to for objective performance criteria standardize medical device technology? It is possible that Class II device manufacturers may choose the path of least resistance, resulting in less differentiation between products and stifling innovation. Though some may counter that the program is a voluntary “carrot,” FDA has admitted it is considering a “stick” to steer manufacturers in the direction prescribed by the agency. Specifically, FDA may post a list of cleared devices that elect to use traditional, perhaps dated, predicates authorized under the FD&C Act. In support of this position, FDA stated, “[d]oing so would create more transparency about these technologies, with the goal of driving device manufacturers to offer patients devices with the latest improvements.” Manufacturers of “blacklisted” devices may feel differently.

Readers should nevertheless be encouraged that at these crossroads, the agency is soliciting diverse perspectives on issues so fundamental to the future of the 510(k) program. Simultaneous with issuance of the guidance, FDA posed questions that invite stakeholders to help frame how their Class II devices will generally be regulated. The specific questions are:

  • Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?
  • Should the FDA consider using other criteria to inform our point of reference?
  • Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices?
  • Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?

Seldom does the public have the opportunity to influence such foundational questions with real consequences for how devices not only get onto the market but how devices already commercialized may be perceived. Interested readers should submit comments by April 22, 2019 to ensure they are considered before FDA takes action.

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