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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
Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Procedures for Handling Post-Approval Studies Imposed by PMA Order: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Procedures for Meetings of the Medical Devices Advisory Committee: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.