Most of the med-tech companies doing business during the COVID-19 pandemic are experienced and already have their FDA compliance systems in place. However, Dennis Gucciardo, a partner at the D.C. office of Morgan, Lewis & Bockius LLP, told BioWorld that while the FDA will give industry sufficient time to transition their emergency use authorizations (EUAs) to conventional premarket filings, the cost of setting up a quality management system may be greater than some current EUA holders are willing to bear.
Gucciardo noted that most of the devices and diagnostics working under the emergency use authorization (EUA) rubric will fall into the class II bucket, although a number of class II offerings were operating under enforcement discretion rather than the EUA program. Among the questions facing companies that are new to the FDA-regulated device space is whether their EUA-directed studies will stand up to the normal requirements, and what the cost of a full-blown compliance system is likely to be, given that Part 820 is a notoriously expensive regulatory mandate.
All things considered, Gucciardo said, “they’re going to scratch their heads from a financial standpoint about whether they want to take the risk.”
Plan ahead for compliance system
Device makers do not necessarily have to have a fully equipped compliance system in place for a 510(k) product until that product is on the market, but waiting until the last minute is not necessarily a good move. “The last thing you want to do is redo your design documentation” after the device is on the market, Gucciardo said, given the prospect that what is on the market might have to be replaced.
Another question about the EUA program is whether the data used to support the device will suffice to earn a 510(k) clearance or grant of de novo petition. While experienced companies have a good idea of what to expect, “for the new folks, I’m not sure they necessarily looked at all of those requirements as they developed their products,” Gucciardo observed.
The FDA has advised that many diagnostics for the COVID-19 pandemic will have to go through the de novo program due to the lack of a predicate, and Gucciardo noted that that the FDA’s Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, has petitioned industry to file for de novo petitions for their tests even as the declaration of public emergency is still in force. This would ease the path to market for a number of test developers thanks to the establishment of a regulation and the associated special controls, but might also boost test availability for the pandemic.
However, this requires that one company do a lot of heavy regulatory lifting that benefits other companies, and Gucciardo pointed out that a PMA filing, required for a class III designation, offers at least some element of exclusivity thanks to the more demanding path to market. Nonetheless, Gucciardo said that his impression is that most of the devices and tests that have been processed to date under the EUA program fall into existing product codes.
The EUA templates set out by the FDA contain specific benchmarks, such as the number of samples needed to validate a test, but once the pandemic is over, the FDA is going to require that those devices meet the more traditional standards. Gucciardo said that he anticipates that there will be “a battle over how much more data the FDA is going to need” to let a test onto the market. The agency will work to identify existing EUA tests as candidates to establish a classification via the de novo program, which will set up special controls for follow-on devices. However, sponsors of products on the market under the EUA program have presumably collected a considerable body of real-world evidence (RWE), which he said will be an important source of information for companies seeking to economize their path to market.
Another consideration is that some of these tests and other devices have been subject to reporting requirements that do not fall neatly into traditional requirements, such as the medical device report (MDR) system. Sponsors that are new to this highly regulated terrain might not be aware of the difference, and Gucciardo said, “this is one area where these companies are going to have to evolve, and evolve pretty quickly” once the pandemic is in the rear-view mirror.
Transition guidance likely an overarching document
The FDA’s Stenzel has said in the past that while the agency is working on a guidance for transitioning from EUAs to conventional premarket mechanisms, this is still not a priority. Gucciardo said such a guidance is unlikely to provide a ton of granularity regarding the premarket demands for classes of products codes, but the guidance should at least provide some insight as to the timelines for processing such applications.
On the other hand, Gucciardo pointed out that the Biden administration has hinted that it will not lift the state of emergency anytime soon, despite the ongoing roll-out of vaccines. Device makers generally might be concerned that “the FDA is going to pull the rug out from under them and they’re going to be stuck,” he said, but the agency is not likely to be that aggressive. One reason is that the FDA had to put a large number of conventional premarket filings on the back burner because of the pandemic, and thus, “it’s going to be a long process because of the backlog of submissions that were not COVID-19 specific.”
Consequently, sponsors of products accessing the market via EUA programs and enforcement discretion have little to worry about in the near term. The transition “will be orderly. Don’t think the FDA is going to drop the bomb and you’ll lose market share” due to an abrupt shift, Gucciardo said.