K
katastic2908
Good Morning,
Can anyone help me interpret this? Am I correct in reading it as - If a finished device was manufactured and labeled prior to the 24Sep2016 UDI labeling compliance date that you have until 24Sep2019 (1 year after the direct marking compliance date for Class II) to put a direct mark on those products, but if it was manufactured and labeled AFTER 24Sep2016 that we have until 24Sep2018 to direct mark it?
"Under 21 CFR 801.30(a)(1), a finished device manufactured and labeled prior to its compliance date for 21 CFR 801.20 is excepted from UDI labeling requirements until three years after the UDI compliance date for 21 CFR 801.20 for that particular device. Because direct marking requirements and GUDID data submission requirements are tied to the UDI labeling requirement at 21 CFR 801.20, the exception at 21 CFR 801.30(a)(1) applies to these requirements as well. For devices intended to be used more than once and intended to be reprocessed before each use, the expiration of the three-year exception under 21 CFR 803.30(a)(1) is still based on the
compliance date for UDI labeling requirements under 21 CFR 801.20, not the direct marking compliance date. For example, the compliance date for 21 CFR 801.20 for class II devices that are not implantable, life-supporting, or life-sustaining was September 24, 2016. Thus, an
individual class II device manufactured and labeled on May 1, 2016, that is not implantable, lifesupporting, or life-sustaining and that requires direct marking, would not be required to be in compliance with UDI labeling, GUDID data submission, or direct marking requirements until September 24, 2019."
https://www.fda.gov/downloads/Medic...onandGuidance/GuidanceDocuments/UCM452262.pdf
Can anyone help me interpret this? Am I correct in reading it as - If a finished device was manufactured and labeled prior to the 24Sep2016 UDI labeling compliance date that you have until 24Sep2019 (1 year after the direct marking compliance date for Class II) to put a direct mark on those products, but if it was manufactured and labeled AFTER 24Sep2016 that we have until 24Sep2018 to direct mark it?
"Under 21 CFR 801.30(a)(1), a finished device manufactured and labeled prior to its compliance date for 21 CFR 801.20 is excepted from UDI labeling requirements until three years after the UDI compliance date for 21 CFR 801.20 for that particular device. Because direct marking requirements and GUDID data submission requirements are tied to the UDI labeling requirement at 21 CFR 801.20, the exception at 21 CFR 801.30(a)(1) applies to these requirements as well. For devices intended to be used more than once and intended to be reprocessed before each use, the expiration of the three-year exception under 21 CFR 803.30(a)(1) is still based on the
compliance date for UDI labeling requirements under 21 CFR 801.20, not the direct marking compliance date. For example, the compliance date for 21 CFR 801.20 for class II devices that are not implantable, life-supporting, or life-sustaining was September 24, 2016. Thus, an
individual class II device manufactured and labeled on May 1, 2016, that is not implantable, lifesupporting, or life-sustaining and that requires direct marking, would not be required to be in compliance with UDI labeling, GUDID data submission, or direct marking requirements until September 24, 2019."
https://www.fda.gov/downloads/Medic...onandGuidance/GuidanceDocuments/UCM452262.pdf