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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
Surgical Masks - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Surveillance and Detention Without Physical Examination of Condoms: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Tonometers - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Types of Communication During the Review of Medical Device Submissions: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs): Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
“Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4042 documents.