HI Rashmi,
The FDA UDI regulation released in 2013 provided a UDI exception to Class I devices that have a Good Manufacturing Practices (GMP) Exemption. GMP is also frequently referred to as Current GMP (CGMP). These Class I GMP Exempt devices only need to meet the FDA defined date format of YYYY-MM-DD if the date is placed on the label.
Most Class I devices (77% of the Product Codes) do not have the GMP Exemption and therefore need to comply with UDI regulations. The original Compliance Date these Class I devices was Sep 24, 2018, but the FDA has extended the Compliance Date two years to Sep 24, 2020. Footnote "2" you see in the FDA Notice simply indicates that UDI requirements and therefore the 2 year extension do not apply to Class I devices with the GMP Exemption.
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Gary Saner
Sr Mgr Information Solutions Life Sciences
Reed Technology
Horsham PA
United States
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Original Message:
Sent: 27-Sep-2017 06:48
From: D Michelle Williams
Subject: FDA class I devices - extension of UDI compliance
Hi...
There are two types of Class I devices, Class I and Class I Exempt. If you look at the device classification it will say, "The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files." For these devices you do not need a QS to cover all the elements of the cGMP. You only need complaint files.
Regards,
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D Michelle Williams
United States
Original Message:
Sent: 26-Sep-2017 02:34
From: Rashmi Pillay
Subject: FDA class I devices - extension of UDI compliance
Hi ,
When FDA extended the compliance dates for UDI for Class I devices , it mentions the exemption is for CGMP exempt devices . What does this mean ?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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