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*Rebuilding and Automating the Portfolio for Women Specific Devices

Forecast

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The Food and Drug Administration is seeking to rebuild and automate the Portfolio for Women-Specific Medical Devices to transition from a static file to a sustainable, self-updating intelligence platform. The project involves three primary objectives: reconstructing and quality-assuring the existing portfolio database with all approved or cleared product codes, deploying an AI-driven automated data pipeline connected directly to FDA databases to remove manual queries, and creating an interactive real-time dashboard for CDRH leadership and staff to visualize data without needing technical expertise. This initiative is designed to enhance the CDRH's ability to identify innovation gaps, respond to congressional and stakeholder inquiries, and refine regulatory strategies for medical devices affecting women. By establishing a living system for data management, the agency aims to maintain a permanent and scalable resource for monitoring women's health medical device trends and regulatory oversight.

General Info

FDA seeks an automated, AI-driven intelligence platform for women-specific medical device portfolio management.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541512 - Computer Systems Design Services

Place of Performance

USA

Set-Aside

NONE

Documents

No documents available

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cdrh Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full 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.