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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
510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments  Food and Drug Administration (FDA) Final
510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants  Food and Drug Administration (FDA) Final
Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Acute Bacterial Exacerbations of Chronic Bronchitis in Patients  Food and Drug Administration (FDA) Final
Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities  Food and Drug Administration (FDA) Final
Antidepressant Drugs--Clinical Evaluation  Food and Drug Administration (FDA) Final
Chapter 1 - General  Food and Drug Administration (FDA) Final
Chapter 2 - Biologics  Food and Drug Administration (FDA) Final
Chapter 3 - Devices  Food and Drug Administration (FDA) Final
Chapter 4 - Human Drugs  Food and Drug Administration (FDA) Final
Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer]  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.