The U.S. Food and Drug Administration (FDA) is seeking an increase of over $550 million in its total proposed budget for fiscal year (FY) 2022, reflecting in part a significant increase in its budget for oversight and administration of its medical device review programs.
According to a recent posting on the website of Medical Design & Outsourcing, the FDA’s total proposed budget of $6.5 billion includes $571 million for the Center for Devices and Radiological Health (CDRH) and over $105 million for the Office of Regulatory Affairs (ORA). This represents an increase of nearly $50 million (7%) for both departments over their proposed budgets in FY 2021. While about $5 million of this amount would be covered by an increase in user fees, the balance would be funded by the federal government.
In its budget proposal to Congress, the FDA is also reportedly seeking increased authority to obtain accurate supply chain information on critical medical devices. The agency says that access to this information can help to preemptively address device shortages while also extending the agency’s oversight of counterfeit medical devices.