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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Safer Technologies Program for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs): Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories  Food and Drug Administration (FDA) Proposed
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees: Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff  Food and Drug Administration (FDA) Proposed
Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry: Draft Revised Draft  Food and Drug Administration (FDA) Proposed
Solicitation of Information and Recommendations for Developing OIG Compliance Program Guidance for Certain Medicare+Choice Organizations  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
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