Innovative Digital Health Devices Regulatory Review and Evaluation Capability
Forecast New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $1,500,000 to $3,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CDRH Acquisition Liaison cdhracquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring contract support to design, pilot, and operationalize an end-to-end review model for innovative digital health medical device submissions through a Digital Health Center of Excellence, with solicitation release estimated for February 1, 2027 and award targeted for August 1, 2027. All regulatory review judgments and decisions remain the responsibility of federal CDRH personnel; the contractor provides capability support only.
The estimated award value ranges from $1.5 million to $3 million. Questions and inquiries should be directed to cdhracquisitions@fda.hhs.gov.
Forecast text
establish a contract-supported capability to design, pilot, and operationalize the Digital Health Center of Excellence end-to-end review model for innovative digital health medical device submissions, with all regulatory review judgments and decisions remaining the responsibility of federal CDRH personnel.
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