The FDA listed a $5 million increase toward improving the safety and security of medical devices in the budget request.
“Developing a more comprehensive cybersecurity program for medical devices will help to identify and mitigate vulnerabilities that could compromise medical systems or disrupt device manufacturing or consumer use, placing national security at risk,” according to the budget request. “Dedicated base funding for a cybersecurity program will allow for FDA to hire additional staff to recruit and develop greater cyber expertise within the devices program, as well as administer grants and contracts to develop infrastructure geared towards addressing emerging cybersecurity challenges.”
The total $8.4 billion budget request is a nearly 34% increase over the agency’s FY 2022 appropriated funding level for investments in medical product safety programs, critical public health modernization, and other vital public health infrastructure.
The request includes $3.7 billion in budget authority an increase of $153 million. The request also includes $1.6 billion in mandatory funding to support the FDA’s ability to prepare for future pandemics.
“The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities. The FDA has focused our budget request on some of today’s most urgent needs such as human and animal food safety, medical device security and e-cigarette oversight. We also continue to look ahead at our role in public health, including at ways to modernize our efforts to keep pace with evolving science, technology and potential public health emergencies,” says FDA Commissioner Robert M. Califf, MD. “Additional funding brings new ways to leverage opportunities to protect and advance the health of every American with reliable and science-based information. We look forward to continuing our work with Congress to help meet the critical public health challenges ahead.”
The FY 2023 request, which covers the period from Oct. 1, 2022, through Sept. 30, 2023, fully funds initiatives previously requested in the FY 2022 budget request and includes new efforts for high priority program areas.
The FDA’s budget proposal also includes a package of legislative proposals designed to bolster the its authorities to further its mission to protect and promote public health. Notable proposals include efforts to assure a more resilient domestic supply chain for medical devices.
This would include authority to require certain firms to provide notification of potential shortages with production volume information. Additionally, it would establish a requirement for device manufacturers to perform risk assessments, implement risk management plans and identify alternate suppliers and manufacturing sites. The FDA is also proposing the temporary importation of unapproved devices, with appropriate scientific and regulatory controls, when needed to prevent or mitigate a shortage.