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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
Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Medical Device Tracking : Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Medical Glove Guidance Manual: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Non-clinical Information for Femoral Stem Prostheses: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Pre-Clinical and Clinical Studies for Neurothrombectomy Devices: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4744 documents.