The Center for Devices and Radiological Health has been focusing on returning to normal operations for the past year and a half. Back in December 2020, Jeff Shuren, the CDRH director, stated that the center would have a restart after the pandemic, which derailed things for them as much as it did for everyone else.
However, 2021 brought the Omicron variant and a rise in COVID-19 cases, so the FDA was forced to push back other projects to focus on the main priority. This past April 29, Shuren attended an event and said that the main goal is to return to normal operations by the end of the year.
He also talked about the budget the FDA was proposing for devices and shared that they were including essential projects into the request regarding supply chain programs and cybersecurity, among other things.
FDA Budget Proposal Details
The FDA’s 2023 budget proposal is requesting $5.5 million to work on an improved cybersecurity program focused on medical devices. That is a $5 million increase from the budget proposal they presented for this year.
The healthcare sector has always been targeted by cybercriminals and, during the pandemic, there was an increase in cyber threats and attacks. Many experts have raised the alarm about the outdated security systems in place, which make medical devices and larger networks extremely vulnerable.
Not long ago, the FDA published a draft guidance based on cybersecurity that explored some of the biggest concerns around risks. The budget proposal explains that the new program will support the CDRH in improving the safety and security of medical devices, and addressing cybersecurity risks related to both legacy and new medical devices.
Shuren stated that the budget increase will help the CDRH have a “serviceable program” to address the issue of cybersecurity in medical devices. Said program is necessary because the White House and government agencies rely on them for guidance when it comes to identifying cybersecurity issues in medical devices.
He shared that they work with developers to ensure that the devices are designed with cybersecurity in mind and commit to regular monitoring, create solutions, and work alongside companies and other people to launch the devices.
Shuren also said that threats targeted towards devices are not the only concern because medical devices belong to a network. And said network is only as safe as its weakest link.
Cybersecurity Is Not the Only Focus
The FDA is not only focused on cybersecurity, they also seek to increase its budget and its authority over the medical device chain of supply. The budget proposal is requesting $21.6 million to establish a first-ever program focused on the resilience of the medical device chain of supply.
The CDRH has no funding or authority related to the supply chain monitoring program before the COVID-19 pandemic. Shuren stated that this forced the country to rely on guesswork. They received $5 million and the authorization to require reports on the chain of supply for critical medical devices thanks to the COVID-19 legislation. However, this will only last as long as the pandemic does.
Shuren explained that the CDRH should be receiving that information not just in the context of the pandemic because device shortages occur very often for other causes.
This budget increase request regarding the medical device supply chain is meant to help the program predict potential shortages and issues based on chain of supply data. This is one of the main priorities for CDRH because, otherwise, it will lead the country right back to where it was before the pandemic hit.
