ForecastedOpportunity FOR-FD-23-012

African Medical Devices Regulatory Harmonization Program

Food and Drug Administration · Department of Health and Human Services

At a glance

African Medical Devices Regulatory Harmonization Program is a forecasted federal cooperative agreement opportunity from the Food and Drug Administration (Department of Health and Human Services). The agency has forecast this opportunity but has not yet set an application deadline. Applicant types listed as eligible include others (see notice). Cost sharing is not required. It is funded under Assistance Listing 93.103 (Food and Drug Administration Research).

Summary assembled from the official notice's fields. The official notice governs.

Key facts

Posted: Jul 6, 2022
Est. close date: Not listed
Award floor: Not specified
Award ceiling: Not specified
Est. total funding: Not specified
Expected awards: Not specified
Cost sharing: Not required
Funding instrument: Cooperative Agreement
Opportunity category: Discretionary
Fiscal year: FY2023

Typical awards for this program (SAM.gov listing for ALN 93.103, not this notice): Varies by grant mechanism and program specific requirements.

Who can apply

Others (see notice)

Additional information on eligibility (from the notice)

Sole Source

Can your organization apply?

A quick check against the listed applicant types — other requirements in the notice still apply.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

The purpose of this program is to enable harmonized approaches, standards and guidelines in order to strengthen innovation, development, regulation and availability of medical devices that meet quality and safety requirements in the African continent. These efforts are critical to ensure consistent and aligned practices for the regulatory oversight of medical devices and to prevent the use or export of poor quality products that can lead to health consequences and increased expenditures.

How to apply

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Read the full announcement (NOFO)Eligibility, evaluation criteria, page limits and required attachments are in the full notice on Grants.gov. Open ↗
Confirm eligibility and fitCheck your organization type above; no cost sharing is required.
Register (or renew) in SAM.gov and get a UEIFree. New registrations can take several weeks; registrations must be renewed every year. Open ↗
Set up Grants.gov accessCreate a Grants.gov account and make sure someone has the Authorized Organization Representative (AOR) role. Open ↗
Watch for the full noticeSave this grant to track when it opens.
Prepare narrative, budget and attachmentsFollow the notice's format exactly — page limits and required forms are common reasons applications are rejected.
Ask the agency contact any questions earlyShashi Malhotra Grants Management Specialist · shashi.malhotra@fda.hhs.gov Open ↗
Submit before the deadlineSubmit a few days early and keep your Grants.gov confirmation and validation emails.

Assistance Listing

What is an ALN?

93.103Food and Drug Administration ResearchProgram →

Reported obligations under ALN 93.103

Historical data · not a prediction

FY18

$173M

FY19

$199M

FY20

$212M

FY21

$219M

FY22

$256M est.

FY23

$247M est.

Source: SAM.gov Assistance Listing 93.103. Program-wide totals, not awards from this specific opportunity.

Who was funded under ALN 93.103

Historical data · not a prediction

Since October 1, 2023, 991 grant awards had funding actions under Food and Drug Administration Research, with 430 sub-awards passed on to other organizations. These are program-wide awards, not awards from this specific notice.

THE CRITICAL PATH INSTITUTE$56.2M
NATIONAL ENVIRONMENTAL HEALTH ASSOCIATION$39.7M
ASSOCIATION OF FOOD & DRUG OFFICIALS$29.5M
DUKE UNIVERSITY$19.1M
THE MEDICAL DEVICE INNOVATION CONSORTIUM$15.6M

Recipients, states, recent awards and sub-awards →Source: USAspending.gov.

Agency contact (as published)

Shashi Malhotra Grants Management Specialist
shashi.malhotra@fda.hhs.gov
2404027592

Quick answers

Is “African Medical Devices Regulatory Harmonization Program” open for applications yet?

Not yet. It is a forecast — an agency's advance notice of an expected opportunity. Forecast details and dates can change.

Who is eligible to apply for “African Medical Devices Regulatory Harmonization Program”?

The official notice names these applicant types as eligible: Others (see notice). Additional restrictions may apply; review the full notice.

How do I apply for “African Medical Devices Regulatory Harmonization Program”?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity FOR-FD-23-012), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.

OpenResearchALN 93.103