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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
Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers  Food and Drug Administration (FDA) Final
Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles  Food and Drug Administration (FDA) Final
Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes  Food and Drug Administration (FDA) Final
Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k)  Food and Drug Administration (FDA) Final
ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents  Food and Drug Administration (FDA) Final
Immunotoxicity Testing Guidance  Food and Drug Administration (FDA) Final
Information for Healthcare Organizations about FDA's "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software"  Food and Drug Administration (FDA) Final
Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment A  Food and Drug Administration (FDA) Final
Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests  Food and Drug Administration (FDA) Final
Kit Certification for 510(k)s  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.