Unique device identification: policy regarding compliance dates for class I and unclassified devices and certain devices requiring direct marking : immediately in effect guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, July 1, 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Equipment and Supplies -- standards Medical Device Legislation Product Labeling United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- FDA's unique device identification system is designed to adequately identify devices through distribution and use.1Its 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) devices are: September 24, 2018, for the following requirements: (1) Standard date formatting (21 CFR 801.18), (2) Labeling (21 CFR 801.20, 21 CFR 801.50), and (3) Global Unique Device Identification Database (GUDID) data submission (21 CFR 830.300); and September 24, 2020, for direct mark requirements (21 CFR 801.45). This guidance describes FDA's intention with regard to enforcement of these requirements for class I and unclassified devices. This guidance also describes 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 (6 pages)).
- NLM Unique ID:
- 9918227978906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918227978906676