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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57): Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Final
Multiple Function Device Products: Policy and Considerations: Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Final
Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Final
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 3123 documents.

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