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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
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.