FDA Budget Request Includes Medical Device Provisions

The FDA is requesting $7.2 billion as part of the president's fiscal year (FY) 2024 budget, which covers the period from October 1, 2023 through September, 30, 2024. Of this budget, the agency intends to put $11.6 million toward improving the medical device supply chain and shortage programs, to ensure patients have access to medical devices at all times. The budget will allow the FDA to expand efforts to work proactively with medical device companies, health care providers, device distributors, and patients to enhance resiliency in the supply chain of critical medical devices and prevent shortages of critical devices that most often impact vulnerable populations.

To complement the funding requests, the agency's budget proposal also includes a package of legislative proposals designed to bolster the FDA's authorities. In the medical device area, the proposal asks to remove limitations that require manufacturers to notify the FDA about interruptions or discontinuances in the manufacture of certain medical devices only during or in advance of a Public Health Emergency (PHE).

The FDA said in a press release that medical device shortages occur in many situations that fall outside of or are unrelated to PHEs, including natural or human-made disasters, recalls, geopolitical conflicts, production shutdowns and cybersecurity incidents. These events can lead to device shortages that significantly impact patient care and jeopardize healthcare worker safety. Therefore, the FDA is seeking the requirement for manufacture notifications at all times, as well as the authority to require and review risk management plans to help ensure that manufacturers are prepared for situations where their ability to manufacture product may be disrupted or may be insufficient to meet demand.

Reference: FDA Seeks $7.2 Billion to Protect and Advance Public Health by Enhancing Food Safety and Advancing Medical Product Availability. SILVER SPRING, Md., March 9, 2023 /PRNewswire.