The budget request includes full funding of the agency’s fiscal 2022 budget request, plus new programs and initiatives that would affect medical device developers and manufacturers.
The FDA also offered complementary legislative proposals such as cybersecurity requirements for medical device manufacturers, remote inspections and supply chain shortage reporting.
FDA budget request highlights for medical device developers and manufacturers include:
The request includes $1.6 billion in mandatory pandemic planning funding over five years, including resources for the FDA to “modernize its regulatory capacity by strengthening its IT and laboratory infrastructure;” to focus on vaccine and therapeutic evaluation; to facilitate rapid diagnostic development; and to help expand the personal protective equipment supply chain.
- $20 million for Cancer Moonshot research, collaborations, outreach and support of development and regulation of oncology medical products through the FDA Oncology Center of Excellence;
- $5 million increase for medical device and medical system cybersecurity and safety, including vulnerabilities that could disrupt device manufacturing;
- $5 million increase for premarket animal drug submission reviews;
- $30 million to decrease opioid exposure, prevent addiction, support treatment, and develop new pain treatments.
- $68 million to invest in technology, including “data-informed capabilities, such as artificial intelligence, machine learning and state-of-the-art solutions like blockchain” to support public health
- $24 million for more efficient food and medical product inspections, additional staff and expanded use of tools “to keep pace with rapidly expanding industry including medical counter measures and advanced manufacturing;”
- $5 million in funding for a New Alternative Methods Program to refine, reduce and replace animal testing.
“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,” he continued. “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.”