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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
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
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 in 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
Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.