*Rebuilding and Automating the Portfolio for Women Specific Devices

Forecast New Requirement Updated

Agency
Solicitation expected
Estimated value
$700,000 to $1,500,000
Set-aside
No set-aside

Forecast facts

Anticipated award
NAICS code
Not on record
Points of contact

Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.

About this forecast

The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is procuring services to rebuild and automate its Portfolio for Women-Specific Devices, with an estimated solicitation release on January 1, 2027, and award targeted for August 1, 2027. The effort encompasses three interdependent objectives: reconstructing and quality-assuring the portfolio database to incorporate all medical device product codes approved or cleared since the original build; architecting and deploying an automated data pipeline that connects directly to FDA databases and uses AI capability to eliminate manual queries; and developing an interactive, real-time dashboard enabling CDRH leadership and program staff to query and visualize medical device portfolio data without specialized technical skill. The deliverable is a permanently sustainable, self-updating intelligence platform for women's health medical devices designed to replace a static file with a living system that positions CDRH to identify innovation gaps, respond to stakeholder and congressional inquiries, and inform regulatory strategy.

The estimated award value ranges from $700,000 to $1.5 million. No set-aside applies to this procurement. Inquiries should be directed to cdhracquisitions@fda.hhs.gov.

Forecast text

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.

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