Research & Education of Medical Device Countermeasure Development & Availability
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 923120 Administration of Public Health Programs
- Points of contact
-
- Joshua Holliday joshua.holliday@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Department of Health and Human Services Food and Drug Administration is seeking research and development services focused on medical device countermeasures for public health emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents and emerging infectious disease threats. The contract aims to support regulatory science, site visits, reviewer education and training, and enhanced review processes to foster medical countermeasure device development and availability. The estimated solicitation release date is April 1, 2026, with an anticipated award date of June 1, 2026.
While specific award values are not provided, the contract is structured to support implementation of Public Law 113-5 and Public Law 115-2, which enable FDA to authorize emergency uses for medical devices to reduce potential casualties and injuries from CBRN agents. The primary point of contact for this opportunity is Joshua Holliday, who can be reached at joshua.holliday@fda.hhs.gov within the FDA organization. The contract will support broader national preparedness efforts by strengthening the regulatory framework for medical device development during potential public health emergencies.
Forecast text
Public Law 113-5 (also known as the Pandemic and All-Hazards Preparendess Reauthorization Act) contains legal authorities to sustain and strengthen our Nation's preparedness for public health emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, as well as emerging infectious disease threats. It's provisions further FDA's mission of fostering the development and availability of medical countermeasures devices in emergencies through funding of regulatory science, site visits, reviewer education and training, and enhanced review processes. These MCM efforts also support Public Law 115-2 which enables FDA to authorize additional emergucency uses for medical devices to reduce deaths and severity of injuries caused by biological, chemical, radiological or nuclear (CBRN) agents or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to the U.S. military forces and for other purposes
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