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HHS Guidance Submissions

HHS Guidance

* Metadata including document title and file name are searchable, however, the contents of the guidance documents that are not in HTML format are currently not keyword searchable.

Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
General Considerations for Animal Studies for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders  Food and Drug Administration (FDA) Proposed
Solicitation of Information and Recommendations for Developing a Compliance Risk Guidance for the Ambulance Industry  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Draft OIG Supplemental Compliance Program Guidance for Nursing Facilities  Office of Inspector General (OIG) Proposed
Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (Chinese Translation)  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry  Food and Drug Administration (FDA) Proposed
2021 Key Dates Table   Centers for Medicare & Medicaid Services (CMS) Proposed
This Guidance Portal contains 46923 documents.

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