Susana,
Medical Device Tracking under 21 CFR Part 821 is specific to certain devices which 1) reasonable concern of safety (adverse events), 2) implant more than 1 year, or 3) life-sustaining. As part of the regulatory submission, this can be clarified with the reviewer if the product would fall under 21 CFR Part 821 or if even an exemption may be possible. This is quite specific so getting expert assistance would be advisable, though if a quality system for say implant cards has been done, may comply with some of the requirements under Part 821.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 27-Nov-2021 11:17
From: Dan O'Leary
Subject: Medical device tracking FDA
Under the FDA regulations, Part 821 implements the tracking requirements. There are also some guidance documents.
I taught this in my regulatory course and had one client ask for help in setting it up. Fortunately, they didn't get a tracking order, so we stopped the project.
Don't be confused my many misstatements about UDI. UDI does not provide device tracking, only identification.
The basic idea in device tracking is that you know the "location" of each tracked device so you could inform FDA and the device user of a problem. The rules have specific times for this activity.
Device tracking can be a little complicated depending on some aspects of the device. For example there is one set of rules for devices used on only patient and another set of rules for devices used on more than one patient and come back to a distributer between patients.
If you have a Part 821 tracked device you will get a tracking order from FDA.
Part of the regulation requires a database and sampling plans for data integrity. Audit the database statistically relevant sampling of the data at not less than 6-month intervals for the first 3 years of distribution and at least once a year thereafter.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 12-Nov-2021 08:19
From: Susana Hidalgo
Subject: Medical device tracking FDA
Greetings
Any one with experience implementing Medical device Tracking for new products under FDA
Thanks
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