Dive Brief:
- Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health (CDRH), said on April 29 that the center is planning to get back to more normal operations by the end of the year even amid ongoing COVID-19 work, a goal the official has repeated at several events over the course of the pandemic.
- Shuren, who spoke at a virtual event held by the Alliance for a Stronger FDA, said that the CDRH is still receiving about 120 emergency use authorization applications or pre-EUA applications for COVID-19 every month, and in 2021, the center had the highest number of 510(k) applications it has had in the last 15 years. Still, Shuren said the majority of the center should be operating normally by the end of the year and the director laid out key budget priorities for the devices regulator in 2023.
- The CDRH director also addressed criticisms after missing a congressional deadline for the fifth Medical Device User Fee Amendments (MDUFA) agreement. After Sen. Richard Burr, R-N.C., grilled Shuren last week for missing the MDUFA deadline and goals, Shuren on April 29 called the criticism “tough love.”
Dive Insight:
Getting back to normal operations has been a goal and talking point for the CDRH over the last 18 months. In December 2020, Shuren said during an Alliance for a Stronger FDA event that 2021 would be a reset after the pandemic derailed work in 2020.
However, the omicron surge forced the FDA to focus on COVID-19 work and push back other projects. Shuren said in September that the CDRH had new priorities to work on last year but decided to not make any changes and focus primarily on the pandemic.
The director said during the April 29 event that even with ongoing COVID-19 priorities, the “goal is to get most of the center back to normal operations by the end of this year.”
Shuren also discussed the FDA’s proposed budget for devices and explained key projects built into the request, such as cybersecurity and supply chain programs.
In the 2023 budget proposal, the FDA is asking for $5.5 million to develop a better cybersecurity program for medical devices, which is a $5 million increase from this year’s funding.
While healthcare has traditionally been a target of cyberthreats, attacks have increased during the pandemic. Experts have cautioned that outdated security systems in medical devices are leaving larger networks vulnerable to attacks.
The FDA recently released a draft guidance on cybersecurity that addresses some concerns regarding risks, which is currently open for comment. The budget proposal states the new program will help the CDRH "improve the safety and security of medical devices, help address risks with legacy devices and rapidly address new medical device cybersecurity vulnerabilities."
Shuren said that the $5 million increase will at least help the center have a “serviceable program” for device cybersecurity, which is needed because the White House or government agencies like the FBI and the Cybersecurity and Infrastructure Security Agency turn to the CDRH for help when identifying medical device cybersecurity problems.
“Of course, we got to work with developers to make sure that devices are designed to be cyber-safe, and then engage in constant monitoring and development solutions and working with companies and others to roll those out. So, we've got to have a core capability,” Shuren said. “[It’s] not just threats to the devices themselves, it's to national security because these are network devices and your network is only as safe as your weakest link.”
The FDA also is seeking increased funding and expanded authority over the medical device supply chain. According to the agency's budget proposal, the $21.6 million in requested funds will help establish a “permanent program for U.S. supply chain resilience for medical devices for the first time.”
Before the pandemic, the CDRH had no authority or funding for a supply chain monitoring program, which Shuren said forced the U.S. to “fly blind.”
The center was given authority to require supply chain reporting for critical devices as part of COVID-19 legislation as well as $5 million from Congress for 2022, according to Shuren, but those will only last for the duration of the pandemic.
“We should be getting that kind of information outside of pandemic because we deal with device shortages all the time,” Shuren said. “Doctors and patients don't care what the cause of the shortage is, they just care that they don't have critical medical devices that they need to assure the health and quality of life of patients.”
The director said that the increased funding proposed for 2023 also will help the program use supply data to predict where potential shortages and problems may arise.
“If we don't have those dollars … we won't be able to maintain it, and the U.S. will be right back where it started pre-COVID days,” Shuren said, calling the funding a “top priority” for the center.
Regarding MDUFA V, the CDRH director brushed off the criticisms the center has been getting for missing the congressional deadline and not hitting its pre-established goals, saying it was “basically Congress doing its job.”
Shuren said that the CDRH plans to have the final MDUFA V package to Congress by the end of the week.
