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*Advancing Home as a Health Care Hub: Building Sustainable CDRH Capabilities for

Forecast
Federal

Contract Overview

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

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The Food and Drug Administration is forecasting a two-year investment for fiscal year 2027 aimed at advancing the home as a health care hub by building sustainable capabilities within the Center for Devices and Radiological Health. This initiative is designed to address the growing connectivity and complexity of medical technologies used in home settings through a coordinated effort across five strategic areas. Key objectives include conducting stakeholder analyses to create external resources, establishing a Home Use Training and Education Program to standardize industry and agency expertise, and improving the collection of real-world evidence regarding device performance. Additionally, the project will explore a Home-Ready Regulatory Framework to streamline and scale regulatory reviews while developing the operational infrastructure necessary to sustain these home health activities.

General Info

FDA two-year investment to enhance home health care device capabilities and regulatory frameworks.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541611 - Administrative Management and General Management Consulting Services

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

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Organization & Contact Information

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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

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This investment would establish sustainable CDRH capabilities to support the increasing number, connectivity, and complexity of medical technologies used in the home. This FY27 investment would initiate a coordinated two-year effort across five mutually reinforcing area: (1) a comprehensive analysis of stakeholder insights resulting in external resources 2) a comprehensive Home Use Training and Education Program to build CDRH expertise and establish a common baseline for industry; (3) improved access to real-world evidence on device performance and challenges in the home; (4) exploration of a Home-Ready Regulatory Framework to standardize common home-use considerations and support more scalable regulatory review; and (5) operational infrastructure and support to sustain these and broader HHH activities.

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