Simpler Grants.gov #FOR-FD-23-012

FDA Solicitation for African Medical Devices Regulatory Harmonization Program

This opportunity is issued by the Food and Drug Administration (FDA) to support the African Medical Devices Regulatory Harmonization Program. - Government Buyer: - Food and Drug Administration (FDA) - OEMs and Vendors: - No specific Original Equipment Manufacturers (OEMs) or vendors are named in this solicitation - Products/Services Requested: - No specific products, part numbers, or purchase quantities are listed - The program seeks to fund activities that harmonize regulatory approaches, standards, and guidelines for medical devices across Africa - Focus is on strengthening innovation, development, regulation, and availability of quality and safe medical devices - Unique or Notable Requirements: - Funding instrument is a cooperative agreement - Opportunity is discretionary and sole source - No cost sharing or matching requirement - Emphasis on science, technology, and research and development activities - Place of Performance/Delivery: - FDA is the contracting office; no specific delivery or performance location in Africa is listed

Description

The program aims to enable harmonized approaches, standards, and guidelines to strengthen innovation, development, regulation, and availability of medical devices that meet quality and safety requirements in Africa. It focuses on ensuring consistent regulatory oversight to prevent the use or export of poor quality medical devices that could lead to health consequences and increased costs. The program is funded through a cooperative agreement and is discretionary in nature, targeting science, technology, and research and development activities.

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