Hi everyone,
My company makes Class II medical device softwares. I was wondering if we have to register our pre-existing Class II softwares in GUDID? We currently do not have our class II medical device softwares listed in the GUDID account. It is my understanding that devices manufactured and labeled prior to compliance date is exempt from the UDI requirement up to 3 years.
Following excerpt is taken from Unique Device Identifier System: Frequently Asked Questions, Vol. 1 issued on August 20,2014.
A.11. Question: Are devices manufactured and labeled prior to the compliance date subject to UDI requirements?
UDI requirements apply to devices placed into commercial distribution after the compliance date that applies to the device. A finished device manufactured and labeled prior to its compliance date and held in inventory is excepted from UDI requirements for three years after the compliance date. This exception applies to both products held in inventory by the labeler and those consigned to a hospital or other potential purchaser and held in inventory, but not yet purchased, by the potential purchaser. This exception applies to all UDI requirements.
Our plan is to register our softwares for upcoming software update that will include UDI in user manual, "about" dialog in the software, etc. But since our GUDID account does not currently list our class II softwares, are we being non-compliant to 21 CFR 830 UDI?
Any input are greatly appreciated. Thanks!
My company makes Class II medical device softwares. I was wondering if we have to register our pre-existing Class II softwares in GUDID? We currently do not have our class II medical device softwares listed in the GUDID account. It is my understanding that devices manufactured and labeled prior to compliance date is exempt from the UDI requirement up to 3 years.
Following excerpt is taken from Unique Device Identifier System: Frequently Asked Questions, Vol. 1 issued on August 20,2014.
A.11. Question: Are devices manufactured and labeled prior to the compliance date subject to UDI requirements?
UDI requirements apply to devices placed into commercial distribution after the compliance date that applies to the device. A finished device manufactured and labeled prior to its compliance date and held in inventory is excepted from UDI requirements for three years after the compliance date. This exception applies to both products held in inventory by the labeler and those consigned to a hospital or other potential purchaser and held in inventory, but not yet purchased, by the potential purchaser. This exception applies to all UDI requirements.
Our plan is to register our softwares for upcoming software update that will include UDI in user manual, "about" dialog in the software, etc. But since our GUDID account does not currently list our class II softwares, are we being non-compliant to 21 CFR 830 UDI?
Any input are greatly appreciated. Thanks!