[Food and Drug Administration](https://www.fda.gov/)

Forecasted — estimated dates not yet announced

Not specified; cooperative agreement, award ceiling/floor TBD

Supports harmonization of medical device regulations across Africa to improve quality, safety, and access to essential healthcare technology.

This is a forecasted, sole source opportunity; eligibility is highly restricted.

--- ## Description This program aims to enable harmonized approaches, standards, and guidelines for the regulation of medical devices across the African continent. The goal is to strengthen innovation, development, regulatory oversight, and the availability of medical devices that meet quality and safety requirements. By aligning regulatory practices, the program seeks to prevent the use or export of substandard products, reduce health risks, and avoid unnecessary healthcare expenditures. --- ## Due Dates - This is a **forecasted opportunity**; specific application deadlines have not yet been announced. - Researchers should monitor the [official Grants.gov listing](https://www.grants.gov/search-results-detail/341844) for updates. --- ## Funding Amount - **Award size and total program funding are not specified** in the current forecast. - Funding will be provided as a **cooperative agreement**. - Award ceiling and floor are to be determined upon official announcement. --- ## Eligibility - **Eligibility is highly restricted**: The opportunity is listed as "Sole Source," meaning only a specific organization or entity is expected to be eligible. - The official listing states: "Eligible Applicants: Others (see text field entitled 'Additional Information on Eligibility' for clarification)." - Researchers should confirm their eligibility before preparing an application. --- ## Application Process - As this is a forecasted opportunity, the application process has not yet opened. - Interested parties should: - Regularly check the [Grants.gov opportunity page](https://www.grants.gov/search-results-detail/341844) for updates and the official Notice of Funding Opportunity (NOFO) when released. - Review eligibility requirements carefully once the full announcement is posted. - Prepare to submit through Grants.gov if eligible. --- ## Additional Information - No cost sharing or matching is required. - The funding instrument is a **cooperative agreement**, indicating substantial involvement by the FDA in project activities. - The program is part of the FDA’s efforts to support regulatory science and public health initiatives internationally. --- ## External Links - [Grants.gov Opportunity Listing (Forecast)](https://www.grants.gov/search-results-detail/341844) - [Food and Drug Administration (FDA) Home](https://www.fda.gov/) --- ## Contact Information | Name | Role | Email | Phone | |------------------|---------------------------|-----------------------------------------|---------------| | Shashi Malhotra | Grants Management Specialist | [shashi.malhotra@fda.hhs.gov](mailto:shashi.malhotra@fda.hhs.gov) | 240-402-7592 | | FDA General | General Inquiries | [patientaffairs@fda.hhs.gov](mailto:patientaffairs@fda.hhs.gov) | (888)-463-6332 | ---

African Medical Devices Regulatory Harmonization Program

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