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Open Recommendations (45 total)

Clinical Research: FDA Should Evaluate Its Efforts to Recruit and Retain Its Inspection Workforce

GAO-24-106383
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1 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of FDA should evaluate its recruitment and retention efforts for BIMO investigators—such as increased pay, student loan repayment, and other financial incentives—to determine their effectiveness and incorporate results of this evaluation as appropriate to help ensure the agency is using the most appropriate tools to maintain its BIMO investigator workforce. (Recommendation 1)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Federal Regulation: Selected Emerging Technologies Highlight the Need for Legislative Analysis and Enhanced Coordination

GAO-24-106122
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1 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of FDA should identify and document the specific changes to its statutory authorities that would enable FDA to take the actions it determines best to oversee AI/ML-enabled medical devices, and then communicate these potential legislative changes to Congress. (Recommendation 1)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Food Safety: FDA Should Finalize Plans to Implement Its Rule to Help Trace Source of Outbreaks

GAO-24-106563
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1 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The FDA Commissioner should direct the Center for Food Safety and Applied Nutrition to finalize and document an implementation plan to help the agency achieve its regulatory goal of compliance with the food traceability rule by January 20, 2026. Such a plan should include FDA's resource needs, strategies for facilitating compliance with the rule, and detailed plans for communicating with and educating regulated entities, nonfederal regulatory partners, and FDA regulatory staff about the rule's requirements. (Recommendation 1)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.

Medical Device Cybersecurity: Agencies Need to Update Agreement to Ensure Effective Coordination

GAO-24-106683
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1 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of Food and Drugs should work with the Cybersecurity and Infrastructure Security Agency to update the agencies' agreement to reflect organizational and procedural changes that have occurred. (Recommendation 1)
Open
We will update the status of this recommendation when HHS provides its 180 day letter (expected in summer 2024).

Cosmetic Safety: Better Planning Would Enhance FDA Efforts to Implement New Law

GAO-24-105542
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1 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist assesses the effects of implementing all MoCRA provisions on the current and future workforce. (Recommendation 4)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.

Cosmetic Safety: Better Planning Would Enhance FDA Efforts to Implement New Law

GAO-24-105542
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5 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist reports on key milestones for all MoCRA requirements. Processes for such reporting could be incorporated into an implementation plan for MoCRA. (Recommendation 2)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist adopts effective recruitment and hiring practices for MoCRA implementation, such as customized strategies to recruit highly specialized and hard-to-fill positions. Such practices could be incorporated into a multiyear strategic workforce plan for MoCRA implementation. (Recommendation 7)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist develops a multiyear strategic workforce plan that identifies the needed personnel and capacity, including skills and competencies, to implement all MoCRA requirements. (Recommendation 5)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist develops processes to collect needed data and evidence to measure the agency's MoCRA implementation efforts against requirements identified in the new law. Such processes for data and evidence collection could be incorporated into FDA's implementation plan for MoCRA. (Recommendation 3)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist develops an implementation plan for MoCRA—including a timeline with interim steps and interim deadlines—for completing all MoCRA requirements within the statutorily prescribed deadlines. (Recommendation 1)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
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