In IDE research tracking is also required. In a surgery, we would often provide 3 identical devices to be implanted. It might happen that the surgeon would accidentally destroy the first serial number device and need to use the second. We recorded and controlled all devices and needed to account for any unused device serial numbers.
One of the requirements of a study would be subject travel. We would need to be notified if they left the USA. One subject retired from work and suddenly moved to Mexico with no plan to ever return. They stopped all comms. For the duration of the study the FDA permitted us to use active social media posting to determine the subject's health since they refused all calls and emails and letters. Somewhere in Mexico is a patient with a nerve cuff on his amputated right arm doing nothing.
Original Message:
Sent: 25-Oct-2023 09:28
From: Dan O'Leary
Subject: 21 CFR Part 821 Tracking Requirements
Despite some initial mis-information, UDI does not provide any tracking information; it provides identification information only. From the UDI you cannot identify the location of the device.
In my class I use the analogy of buying a book from Amazon. The package has a tracking number which is scanned by the facility that handles it. It provides a history of where the package has been, but no information about the contents of the package.
On the other hand the book has an ISBN number, analogous to the UDI-DI, that identifies the book but doesn't provide information on the book's location.
Your presumption, "if UDI is the universal mechanism for tracking of all (most) medical devices in the US" doesn't hold. UDI is not for tracking.
The tracking regulation in Part 821 helps facilitate recalls. The manufacturer must maintain a database of the location of all tracked devices. Location is a loose term. For example location of an implant may mean the name of person with the implant, not that she is having lunch as Joe's Bar and Grille.
So in short, there are two different things going on. One is device identification, its attributes, through the UDI regulation. The other is its location through the tracking regulation. A device manufacturer cannot meet the requirements of Part 821 by referring to the UDI.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 24-Oct-2023 21:57
From: Anonymous Member
Subject: 21 CFR Part 821 Tracking Requirements
This message was posted by a user wishing to remain anonymous
So to this question (thanks for the information to date) the "current" guidance addressing Medical Device Tracking https://www.fda.gov/media/71205/download is dated 2014 and speaks of a 'proposed UDI rule' which is obviously effective now. Is the tracking requirement under 21 CFR 821 somewhat redundant to the current UDI program? Presumably, if UDI is the universal mechanism for tracking of all (most) medical devices in the US could one (a manufacturer) arguably address any potential order to track per 821 by using whatever UDI procedure/process they already have in place?
Original Message:
Sent: 20-Oct-2023 07:43
From: Dan O'Leary
Subject: 21 CFR Part 821 Tracking Requirements
Can you give some context to "Device code 821". It is not clear to me that it means FDA will issue a tracking order.
FDA has some guidance documents on when they issue tracking orders. You look them up on the FDA website.
You say your device is Class II. FDA would typically issue the tracking order at the same time as the clearance letter.
Richard said, "While [Part 821] is called post market surveillance, it should not be confused with Post Market Surveillance which would be seen in say EU MDR/IVDR requirements."
This is not quite correct. Part 821 is Medical Device Tracking while Part 822 is Post Market Surveillance. The post-market surveillance in Part 822 is not the same as the post-market surveillance in the EU-MDR/IVDR. If Part 822 post-market surveillance is required, then FDA will notify your company.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 19-Oct-2023 14:43
From: Anonymous Member
Subject: 21 CFR Part 821 Tracking Requirements
This message was posted by a user wishing to remain anonymous
Greetings, forum! In reviewing the product code for a Class II device under development there is a resource that shows it falls under "Device Code 821," which I'm understanding means per 21 CFR 821, Medical Device Tracking, "... the Food and Drug Administration may require a manufacturer to adopt a method of tracking a class II or class III device, if the device meets one of the following three criteria and FDA issues an order to the manufacturer: the failure of the device would be reasonably likely to have serious adverse health consequences; or the device is intended to be implanted in the human body for more than 1 year; or the device is a life-sustaining or life-supporting device used outside a device user facility. A device that meets one of these criteria and is the subject of an FDA order must comply with this part and is referred to, in this part, as a "tracked device."
Can anyone provide insight on what the impetus may be for a manufacturer to be issued "an order" by the FDA requiring this tracking be put in place? Is this something to flag for a premarket submission, or is this something penal that could arise in the post-market phase once the device is out in the wild? Any information appreciated!