Skip to main content
U.S. flag

An official website of the United States government

HHS Guidance Submissions

Search HHS Guidance Documents

 

Filter Guidance Documents by ...

Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
User Fees and Refunds for De Novo Classification Requests : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
User Fees and Refunds for Premarket Notification Submissions (510(k)s) : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
User Fees for 513(g) Requests for Information: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Utilizing Animal Studies to Evaluate Organ Preservation Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 50101 documents.

Petition Submissions

To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov

CDC

CMS

* This PDF is not Section 508 compliant. Assistive Technology users should contact good.guidance@hhs.gov if they experience any difficulties.