The COVID-19 pandemic has not run its course, but the U.S. FDA is already working on a plan for handling devices in the period after the public health emergency ends. Bill Maisel, chief medical officer at the FDA’s Center for Device and Radiological Health (CDRH), said the agency is thinking through what would have to appear in a guidance for a transition that may span a number of months, providing industry with some much-needed breathing room.
Maisel was one of several speakers at a session for the ongoing Advanced Medical Technology Association-sponsored Virtual MedTech Conference addressing the transition from pandemic-related product authorizations to a more conventional situation, adding that the volume of routine 510(k), PMA and other filings hasn’t ebbed as the crisis has unwound. In addition to the standard number of premarket filings, CDRH has authorized more than 500 emergency use authorizations (EUAs), which Maisel said is about 10 times the cumulative count for prior crises of this nature.
Transition may span ‘many months’
The FDA must wait for the Department of Health and Human Services to declare an end to the public health emergency before the agency can commence a withdrawal of any EUA programs, Maisel said. The FDA would post an advanced notice of any transitional mechanism for devices covered by an EUA in the Federal Register, and he said that the agency recognizes the need for a transitional period so device and test makers can rewire their development and regulatory processes. He said CDRH is considering a draft guidance to give industry some insight as to how the agency intends to manage that transition, adding that “over a period of time that would measure many months, there would be a gradual restoration of the typical requirements” associated with device oversight.
Maisel said CDRH is doing its best to provide transparency about any impending regulatory actions, but noted that while previous pandemic experience has been helpful in navigating the current crisis, “this is uncharted territory to a certain degree.” He added that the center staff will examine the processes it has adopted over the past six months to determine which, if any, of them may prove useful in a post-COVID world.
David Boudreau, director of the medical devices office at Health Canada (HC), said HC has made multiple uses of the interim orders (IO) process, which is the most expeditious mechanism available to the agency. IOs have been used for clinical trials and small molecule drug approvals as well as for devices and tests. However, he noted that this latest pandemic is proving much more durable than was perhaps expected at the outset, and thus HC has some orders that may have to be in force longer than a year by the time the crisis has passed.
“We need to be quite agile and responsive,” as a result, Boudreau said, adding that previous outbreaks required relatively little engagement with stakeholders, a stark difference between COVID-19 and its antecedents.
Boudreau said HC has been examining this predicament for the past few months, adding that the drafting of a transition regulation plan is underway. The focus to date has been on ensuring continued access to products that were authorized under the pandemic, but the agency is also interested in seeing any accumulated real-world data, which may prove useful for use subsequent premarket filings.
Boudreau said the agency did not mandate documentation of an inspection certificate under the Medical Device Single Audit Program (MDSA) under the IO for the pandemic, but said the agency is aware that companies will need time to catch up on this requirement. However, HC has yet to settle on the duration of any related grace period, although it will meet with industry to discuss these matters before issuing a policy.
Reclassification-like transitional mechanism a possibility
Maisel said the FDA is concerned that some valuable products may disappear after the pandemic, but noted that the FDA is considering a transitional program that depends on a device’s risk classification. In one possible scenario, that premarket filing would have to be at the FDA within six months of the end of the public health emergency. The manufacturer would be able to continue marketing while the application is under review, however, a mechanism that is similar to that which is used for devices that are up-classified from class II to class III.
Boudreau said HC is considering several options, including one that resembles the type characterized by Maisel. However, HC is intent on drafting a policy that takes up the regulatory status of devices that have been stockpiled during the pandemic under the IOs. Boudreau did not offer any detail as to how the agency might manage any remaining inventory, however.
Maisel sought to quash any concern that the FDA will necessarily have second thoughts about granting a marketing authorization for any product deemed fit for an EUA. If the FDA sees a product as safe and effective the day before the pandemic is over, that view is unlikely to change the day following the end of the crisis. “It’s not like these products suddenly become inherently unsafe,” he said, adding that the agency already has a number of levers to deal with problem devices. “Labeling is a reasonable way to help inform the public” as to the product’s benefit-risk profile, he said, but no action by the sponsor will be necessary merely because of the cessation of the public health emergency, including where single-use devices are concerned.