Civic AI
Civic AI
Procurement intelligence
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*Rebuilding and Automating the Portfolio for Women Specific Devices

Department of Health and Human Services.Food and Drug Administration.75F401.75F402
Est. solicitation
Jan 1, 2027
Date posted
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Description

The Portfolio for Women-Specific Medical Devices would accomplish three interdependent goals: (1) reconstruct and quality-assure the portfolio database, incorporating all medical device product codes approved or cleared since the original build; (2) architect and deploy an automated data pipeline connecting directly to FDA databases, eliminating manual queries, using AI capability; and (3) develop an interactive, real-time dashboard enabling CDRH leadership and program staff to query and visualize medical device portfolio data without specialized technical skill. A permanently sustainable, self-updating intelligence platform for women's health medical devices - replacing a static file with a living system - that positions CDRH to identify innovation gaps, respond to stakeholder and congressional inquiries, and inform regulatory strategy for medical devices affecting women.

Planning details

Estimated value
>= $700K and < $1.5M
Est. solicitation date
Jan 1, 2027
Anticipated award
Aug 1, 2027

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