Pathways' Pick of the Week: FDA's COVID Transition, Phase 2

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ARTICLE SUMMARY:

Updates on FDA’s efforts to transition out of its COVID-19 emergency frameworks. Excerpted from Pathways' Picks August 9: FDA COVID Transitions, Talking LDTs, and Pushback in India.

August 9 was a key date in the transition process outlined by FDA for devices leveraging COVID-19 “enforcement discretion” policies. Specifically, it marked the start of the second of a three phase transition. That means, as of today, manufacturers of various types of ventilators and respiratory equipment that are relying on the pandemic-era regulatory flexibilities must now notify FDA whether they intend to continue marketing the device and ultimately make a marketing submission to FDA. In addition, all devices benefiting from COVID enforcement discretions—including certain digital health products, monitoring devices, and personal protective equipment, among other categories—must comply with standard registration and listing and recall requirements if they are going to stay on the market after today. Manufacturers in this situation have until November 7 (Phase 3) to make an appropriate premarket submission for the device.   

FDA’s device center also recently confirmed that it is accepting requests from companies to meet with review staff in person at the agency’s Silver Spring, MD, headquarters, either for pre-submission meetings or other engagements. In the wake of the pandemic, CDRH had restricted companies to virtual meetings for most of the past three years, although it has opened up to more and more in person meetings over the past year. In an August 2 blog post, center leaders underscored that “we are accepting and holding in-person meetings with stakeholders and have been doing so for quite some time.”

More than 30 devices that originally entered the US market under COVID-19 Emergency Use Authorizations (EUAs) have transitioned to traditional 510(k) or De Novo authorizations, CDRH officials said August 2. Devices on the market with EUAs are distinct from devices leveraging enforcement discretions. The discretions are phasing out after the Public Health Emergency officially ended in May, while EUAs remain in full effect with no sunset date yet designated. (See “CDRH’s COVID-19 Transition Plans: 7 Key Takeaways,” Market Pathways, March 28, 2023.) FDA says it is currently reviewing fewer than 80 EUA submissions, mostly for COVID diagnostics. But the agency is urging companies to pursue traditional authorizations as soon as possible and issued a guidance outlining the transition process in March.

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