What CVM Director Dr. Shuren Said to the Alliance

What CVM Director Dr. Shuren Said to the Alliance

On April 29, 2022, Dr. Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health (CDRH) provided an information-packed webinar for the Alliance. CDRH’s 1,900 employees oversee 230,000 medical devices produced at more than 25,000 manufacturing facilities around the world and 19,000 premarket submissions. They have approved a record number of novel devices, with an average of over 100 per year.

CDRH has dealt with more than 8,000 emergency use and pre-emergency requests since the start of COVID-19. They have authorized about 2,300 medical devices in response.

Significant efforts have been made to increase engagement and transparency during this time. Among other things, CDRH has issued over 350 frequently asked questions, 28 COVID guidances that have been modified 21 times, and responded to 420,000 inquiries. They have held 107 town hall webinars.

There have been ramifications for non-COVID work. Last year saw the highest number of 510(K) submissions in 15 years. They hired more term-appointment staff with COVID Supplemental funds. They also got temporary help from contractors and have changed policies and procedures. The backlog has now been reduced by 45%.

Dr. Shuren said they will soon start to open the door for pre-submissions. The goal is to be back to normal by the end of the year. They also want to transition from emergency use to full use authorizations for several items, and have put out two guidance documents for comment, with the goal of issuing final guidances by the end of this year.

For 2022 they will put a spotlight on some regulatory science research opportunities, including a final report on the pre-certification pilot. Among other things, they are building a Digital Health Policy Navigator to help determine if a product is something that is regulated as a medical device or not by the Center and what are the applicable policies. There will also be draft guidance on the use of a change control plan for technologies that are enabled with artificial intelligence machine learning, explaining what needs to be done if a manufacturer wants to have a plan for making changes and validating them so that CDRH can review them.

With respect to cybersecurity Dr. Shuren spoke about the 2023 budget request for $5 million for a serviceable program on device cybersecurity, and for authorities included PATCH Act introduced in the House (H.R. 7084) and the Senate (S. 3983).

Dr. Shuren responded to several questions, including:

• Changes in regulatory framework – The paradigms developed in 1976 do not work well today. COVID EU authority gave CDRH the ability to respond. There is a need to have agile regulations that provide greater flexibility in how manufacturers can meet standards. Changes in the law will be required.

• Next technologies – Robotics, genomics, probiotics for detection of various pathological conditions, closed loop organs, miniaturization, non-invasive endoscopic surgery, technology that is fit for the home, greater use of breath tests. There is a symbiosis between technology and humans. Technology will increasingly integrate into everyday life, which is exciting, but for which CDRH is not yet fully prepared.

A more complete Alliance summary is here. The transcript of the webinar can be found here.

Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.