Oddly enough, FDA's
medical device recall notification letter template hasn't yet been updated to include a UDI element. But we know that the UDI needs to be, and is expected to be, included in the recall notification letter because a fundamental purpose of the UDI requirement is to improve device recallability. For example, when promulgating the UDI regulations, FDA said, "...
UDIs on all device packages are essential for rapid and efficient identification of devices that are the subject of a recall, a key objective of the UDI rule....
Delays in identifying recalled devices can result in the continued use of those devices on patients and involves an increased risk for patient harm. A device labeled with a UDI can be identified rapidly and with great precision. The more rapidly a recall is implemented and completed, the more rapidly the risks presented are reduced or eliminated..." Given this intrinsic intent of the UDI requirement and the basic purpose of a recall notification letter, it becomes unavoidable that the letter needs to identify the UDI of the affected devices.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 03-May-2022 07:33
From: Janet Price-Lutz
Subject: UDI in customer notification letter
Is the FDA requiring that the UDI be listed in the customer notification letter for medical devices?
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Janet Price-Lutz BS, MPA
Global Post Market Specialist
Bloomington IN
United States
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