CDRH Update and Future Priorities
On December 3, 2020, the Alliance was pleased to sponsor a webinar with CDRH Director, Dr. Jeffrey Shuren.He covered a wide-ranging set of topics and emphasized that the Center has met its pandemic-related responsibilities while maintaining its existing commitments. He hopes that 2021 will be a “reset” year, where more new initiatives can move forward. At the same time, he expects they will see a surge in submissions as developers of COVID-related products seek full marketing approval.COVID-19 Experience. When the COVID-19 pandemic began, CDRH took advantage of regulatory flexibilities provided in Emergency Use Authorizations. The Center received more than 5,000 pre-EUAs and EUAs since the public health emergency began. To assist developers during COVID-19, CDRH set up a hotline and e-mail portal, as well as webinars to help developers bring products to market.The Center also authorized over 600 medical devices in 2020, including tests, ventilators, respiratory devices, personal protective equipment, and renal and cardiovascular devices. During the pandemic, CDRH developed guidance over short periods of time. The guidance on diagnostics was released in 36 hours. Altogether, CDRH promulgated 25 guidances on devices in 2020.Innovation. CDRH’s goal is to bring at least 50% of innovative technologies to the United States first or parallel to other nations. So far, CDRH is exceeding the goal at 69%. However, Dr. Shuren anticipates that, in the short-term, COVID-19 may impede further progress on this goal.Digital Transformation. CDRH is overhauling its legacy IT system to an agile platform that uses cloud-based data. In 2021, CDRH will make the Customer Collaboration Portal available to create a virtual work environment. The center will also offer a tracker for submissions and launch eSTAR for 510(K) submissions. eSTAR will create electronic templates to streamline the review process and allow sponsors to know the precise status of their submissions.Real Word Evidence. Since 2015, RWE has been leveraged in the review of 65 products. The National Evaluation System for Health Technology had a soft launch in June and CDRH will work with the Medical Device Innovation Consortium to integrate RWE in post-market surveillance.Patient-Generated Health Data. CDRH held a meeting in the spring to discuss how to conduct decentralized clinical trials with the help of CDER and CBER. CDRH will also allow patients to provide input in a non-FDA forum in 2021 entitled “Collaborative Communities.”Digital Health Center of Excellence. The Center of Excellence will share expertise within FDA, expand collaboration for digital health technologies, and create new regulatory paradigms for new technologies.The 510(k) Process. Dr. Shuren was asked: will CDRH overhaul the 510(k) process? He replied that CDRH will work to enhance the program in 2021, and further develop the Safety and Performance Based Pathway to allow developers to use FDA-determined performance criteria to prove that a device is as safe and effective as a predicate device.Dr. Shuren concluded by noting that 2021 will have a hard beginning but, hopefully, a soft landing. He thanked his staff, medical device stakeholders, and non-traditional manufacturers for making it possible for CDRH to fulfill its responsibilities in 2020.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA. Special thanks to Reed Diskey for sharing his meeting notes.