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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
General Considerations for Animal Studies for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders  Food and Drug Administration (FDA) Proposed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 Revising the Compliance Program Guidance for the Hospital Industry  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Draft OIG 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Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (French Translation)  Food and Drug Administration (FDA) Proposed
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry  Food and Drug Administration (FDA) Proposed
Amendments to OIG Exclusion and CMP Authorities Resulting From Public Law 100-93  Office of Inspector General (OIG) Proposed
Proposed Rule: Safe Harbor for Federally Qualified Health Centers Under the Anti-Kickback Statute  Office of Inspector General (OIG) Proposed
This Guidance Portal contains 47715 documents.

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