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HHS Guidance Submissions

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Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
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 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
Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals"): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Radiation Biodosimetry Medical Countermeasure Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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