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
- Collection:
- Health Policy and Services Research
- Alternate Title(s):
- 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
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, July 25, 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Databases as Topic Equipment and Supplies Government Regulation Product Labeling United States United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- FDA’s unique device identification system (UDI system) is designed to adequately identify devices through distribution and use. Its requirements were designed to be phased in over seven years according to established compliance dates based primarily on device classification. The compliance dates established for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices2 are: (1) September 24, 2018, for the following requirements: (a) Standard date formatting (21 CFR 801.18), (b) Labeling (21 CFR 801.20, 21 CFR 801.50), and (c) Global Unique Device Identification Database (GUDID) data submission (21 CFR 830.300); and (2) September 24, 2020, for direct mark requirements (21 CFR 801.45). This guidance describes FDA’s policies with regard to enforcement of these requirements for class I and unclassified devices, including the Agency’s compliance policy regarding GUDID submission requirements under 21 CFR 830.300 for certain class I devices considered consumer health products. In addition, the guidance describes how a labeler of a class I device can determine whether its device is within the scope of that compliance policy. This guidance also reiterates FDA’s direct mark compliance policy for class III, LS/LS, and class II devices that are non-sterile, that are manufactured and labeled prior to their applicable direct mark compliance date, and that remain in inventory, as well as for class I and unclassified devices that are not LS/LS devices, that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (10 pages))
- NLM Unique ID:
- 9918486679306676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918486679306676