ARTICLE SUMMARY:
In this week’s roundup: Updates on FDA’s efforts to transition out of its COVID-19 emergency frameworks; groups on all sides of the laboratory-developed test debate come in to talk to FDA in advance of a proposed rule; the domestic device industry in India is pushing back against broad regulatory reform legislation; and more from the US, France and Australia.
Editor’s note: We will not publish Pathways’ Picks next week, August 16. It will be back in your inbox on August 23. Check out Market Pathways’ homepage for more updates and analysis.
COVID Transition Picks
Updates from FDA’s transition:
Welcome to Phase 2. Today, August 9, is a key deadline in the transition process outlined by FDA for devices leveraging COVID-19 “enforcement discretion” policies. Specifically, it is 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.
