Skip to main content
U.S. flag

An official website of the United States government

On October 9, 2019, the President issued Executive Order (EO) 13891 entitled Promoting the Rule of Law through Improved Agency Guidance Documents (84 FR 55235). The EO requires HHS to establish a single, searchable, indexed database that contains links to all of HHS’s guidance documents currently in effect. Guidance documents come in a variety of formats, including interpretive memoranda, policy statements, manuals, bulletins, advisories, and more.

On August 20, 2020, HHS published a Notice of Proposed Rulemaking that proposes to issue regulations governing the agency’s release and maintenance of guidance documents. See 85 FR 51396. These regulations should, if finalized, help to ensure that the public receives appropriate notice of new guidance and that the Department’s guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them. HHS has issued a Request for Information soliciting comments relating to the Department’s current compliance with Executive Order 13891, and in particular, seeks specific feedback about potential opportunities to improve and ensure the Department’s compliance with, and best practices relating to, the legal obligations governing the appropriate issuance of guidance. Comments are due on October 12, 2020 and should be submitted electronically to [email protected].

DISCLAIMER: Please note, the contents of this database do not have the force and effect of law and are not meant to bind the public in any way. These documents are intended only to provide clarity to the public regarding existing requirements under the law or HHS policies.

HHS Guidance Submissions

Title Subtitle OpDiv/StaffDiv Guidance Status Issue Date
Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient Food and Drug Administration (FDA) Final
Guidance for Industry: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal Food Food and Drug Administration (FDA) Final
Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements - Guidance for Industry and for FDA Reviewers/Staff Food and Drug Administration (FDA) Final
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use Food and Drug Administration (FDA) Final
Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment Food and Drug Administration (FDA) Final
Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile Food and Drug Administration (FDA) Final
Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions Food and Drug Administration (FDA) Final
Guidance for Industry and FDA Staff: Spinal System 510(k)s Food and Drug Administration (FDA) Final
Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls Food and Drug Administration (FDA) Final
Guidance for Industry and FDA Staff: Model Accreditation Standards for Third-Party Certification Body Accreditation for Food Safety Audits Food and Drug Administration (FDA) Final
This Guidance Portal contains 26886 documents.
This is archived HHS content.