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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls: Draft Guidance for Industry and FDA Staff   Food and Drug Administration (FDA) Proposed
Requesting FDA Feedback on Combination Products : Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57): Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Final
Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Final
Multiple Function Device Products: Policy and Considerations: Draft Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Proposed
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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