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Innovative Digital Health Devices Regulatory Review and Evaluation Capability
Department of Health and Human Services.Food and Drug Administration.75F401.75F402
- Est. solicitation
- Feb 1, 2027
- Date posted
- —
- Source
- Open forecast
Description
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.
Planning details
- Estimated value
- >= $1.5M and < $3M
- Est. solicitation date
- Feb 1, 2027
- Anticipated award
- Aug 1, 2027