FDA Budget Request for 2023 Contains Increase for Medical Device Program
By: Fran Kritz
Categories: AAMI News, HTM Professionals, Medical Device Manufacturers
The FDA recently submitted its 2023 budget request to Congress, which includes a requested increase for medical devices cybersecurity and supply chain improvements. The full FDA budget request is for $8.4 billion, a 34 percent increase over last year’s appropriation.
“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,” said FDA Commissioner Robert M. Califf, in a press release. “The FDA has focused our budget request on some of today’s most urgent needs” such as medical device security.
The FY 2023 budget request covers the period from Oct. 1, 2022, through Sept. 30, 2023. Specifics of the requested funds include:
- An increase of $5 million over last year allocation toward improving the safety and security of medical devices. According to the FDA, 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. The requested funding would also allow the agency 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.
- An allocation of $24 million to optimize inspections and enhance inspectional capacity. This request is aimed at support for the recruitment and training of new FDA investigators to improve the efficiency of the agency’s manufacturing inspections, including medical devices.
- The budget also calls for Congressional authorizations, including requiring, for the first time, the destruction of imported products by their owner or consignee that have been refused authorization to enter the U.S. and pose a significant risk to public health. The FDA said it believes this new authority would prevent the potential reimportation of these products and would deter owners and consignees from importing products they know to pose a significant public health risk.
- The authority to assure a “more resilient domestic supply chain” for medical devices. This authority would require certain firms to provide notification of potential shortages with production volume information, the FDA wrote. In addition, 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.
“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,” Califf said. “Additional funding brings new ways to leverage opportunities to protect and advance the health of every American with reliable and science-based information.”