Meeting the criteria isn't a tracking order

A device that would kill or seriously injure a patient if it failed, an implant meant to stay in the body more than a year, a life-sustaining machine a patient runs at home instead of in a hospital — each one reads like exactly the kind of device FDA tracks from factory to patient. Reading the regulation shows why that inference, on its own, is not enough. Matching the description is necessary. It is not sufficient.

Three criteria, then a separate act

21 CFR 821.1(a) implements section 519(e) of the FD&C Act and names three criteria under which a Class II or Class III device can become trackable: the failure of the device would be reasonably likely to have serious adverse health consequences; the device is intended to be implanted in the human body for more than one year; or the device is a life-sustaining or life-supporting device used outside a device user facility. Any one of the three is enough to qualify a device for the program.

Qualifying is where the regulation stops short of obligating anything. 21 CFR 821.20 states the actual trigger plainly: a manufacturer of a device that fits one of the three criteria must track it under this part if FDA issues a tracking order to that manufacturer. When FDA does act, the order arrives as its own, separate document — not folded into the 510(k) clearance letter or the PMA approval letter for the same device, even when the order follows directly from that review. Two devices can match the same criterion, from the same product code, and only one of them can be carrying a live order.

The criteria describe which devices FDA is allowed to reach. The order is the only document that says FDA actually did.

What the public list actually is

FDA does publish something in this space: a guidance document, most recently updated in March 2014, that tables the product codes FDA has determined meet the tracking criteria — alongside a separate table of product codes released from the requirement since the prior update. That table answers a category-level question, which product types FDA considers eligible, in the same register as the criteria themselves. It does not answer, for any specific manufacturer’s device carrying one of those codes, whether an order was ever sent, is still in force, or was rescinded. No public database lists active tracking orders by manufacturer or device the way openFDA lists 510(k) clearances or enforcement reports.

The practice

Finding a device on the market that fits one of the three 821.1(a) criteria, and whose product code sits on FDA’s own eligibility table, is a reasonable basis for suspecting a tracking obligation exists — not for asserting one does. The order is a fact only the manufacturer holding it, and FDA, can confirm, and neither is required to publish it anywhere a third party can search. Building a competitive read on whether a device is under an active tracking order from public sources alone means treating the product-code table as a shortlist, not a verdict, and going to the manufacturer’s own SOPs and disclosures — or to FDA directly — for the order itself. This is regulatory intelligence and method, never a determination of any specific device’s tracking status.

Device tracking sits outside FDA Radar’s current source coverage — per what we monitor and how often, the pipeline reads Federal Register notices, warning letters, recalls, and 510(k) clearances, none of which carries a field for a tracking order.