Jeff Shuren shared three lessons FDA learned from CDRH’s experience:

• The importance of flexibility. “During the pandemic, CDRH leveraged its Emergency Use Authorization authority to maximize timely product availability with some assurances of the safety and effectiveness of the devices authorized,” he said. CDRH has authorized over 500 medical devices since February and averaged about 1 test authorized per day. “We also rapidly adapted our polices to meet evolving circumstances on the ground as COVID-19 spread and new information became available,” he said. So far, CDRH issued 23 guidances and 10 EUA templates. “The level of regulatory flexibility has been unprecedented and could serve as a model in the future. However, the challenge we face is that the regulatory paradigm established for medical devices is over 40 years old and not well suited for many modern-day technologies. As we look to the future, we should consider how to make this level of regulatory flexibility of tailoring the regulatory paradigm and the evidence required for full marketing authorization to the technology and its intended use as well as rapidly developing and issuing guidance to establish and adjust policy in near-real-time as circumstances warrant for routine practice in the future.”
   
• The value of engagement. “CDRH took its collaborative approach with developers that we apply in our Breakthrough Device Designation program and essentially put it on steroids,” Shuren said. Communication among the center and developers was in real-time thanks to emails and phone calls, and data was provided for review on a rolling basis, he said. A 24-hour hotline was established, and more than 40 weekly and biweekly webinars for developers were held.
  
  It’s been a very busy time for CDRH. To date, Shuren said they have “received 339,000 telephone and email queries.” On top of receiving the typical number of PMAs received each year, the team received 4700 preEUAs and EUAs. “Our workload more than doubled during this time compared with last year, and yet the number people we have didn’t,” he added.
  
  “The level of engagement we have provided to developers has been instrumental in accelerating the development, validation, and authorization of medical devices during the pandemic,” he said. “In the future, finding ways to provide this level of engagement where it could be most beneficial could have a significantly positive impact and help technology innovation, availability, and patient safety the US.”
   
• The value of the Total Product Lifecycle (TPLC) approach. “Luckily, we had already reorganized within CDRH to restructure our premarket, postmarket, and compliance and quality activities,” Shuren said. As a result, he said the center has been able to “better work with developer and provider communities during the pandemic. In the future we will look for ways to better and more broadly apply the TPLC approach.”
  
  “We are all happy that we implemented TPLC,” added Bill Maisel, MD, MPH, chief medical officer and director, Office of Product Evaluation and Quality, later in the discussion. “It has helped balance enforcement discretion, offers a more streamlined approach, and we are more agile.”

“We look forward to engaging all of you and the rest of the members of our community to better understand and apply lessons learned from COVID-19 so that our post-pandemic future is a brighter one than the world of today,” said Shuren.