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HHS Guidance Submissions

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Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Application User Fees for Combination Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Biological Indicator (BI) Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended – Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
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