Regulation Text
Authority
21 U.S.C. 321,331-334,351,352,360d,360i,360j,371,374.
Related Warning Letters (4)
- 2025-05-20
CGMP/QSR/Medical Devices/Adulterated
NeuroSync, Inc.
- 2024-10-29
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Argon Medical Productions & Vertrieb Gesellschaft MBH & CO
- 2024-07-09
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
AG Essence, Inc.
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
Related Guidelines (9)
Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
→Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry (Status: Draft)
→