FDA Guidance Documents Update

Recently Posted Guidance Documents

6/24/15: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

6/26/15: Unique Device Identification: Direct Marking of Devices - Draft Guidance for Industry and Food and Drug Administration Staff

6/29/15: Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff

6/30/15: Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - Draft Guidance for Industry and Food and Drug Administration Staff

6/30/15: DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry

7/1/15: Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements - Guidance for Industry and Food and Drug Administration Staff

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