FDA and New Requirements for Tracking Medical Devices

Tracking Requirements Relaxed Under FDAAA
Medical devicemakers will be subject to fewer tracking requirements under H.R. 3580, the FDA Amendments Act (FDAAA).

Previously, devicemakers were required to track certain higher-risk devices even if the FDA did not issue a specific order to track a device. Under the new law, tracking will apply only if the FDA issues an order, according to a revised guidance document.

The agency may require tracking for a Class II or III device:

That is a life-sustaining or life-supporting device used outside a device user facility;
That is intended to be implanted in the human body for more than one year; or
Whose failure would be reasonably likely to have serious adverse health consequences.

Tracking methods are subject to FDA inspection, which may include a review of the tracking system and verification of information requirements. Medical device tracking is intended to ensure that manufacturers can promptly identify product distribution information and remove a device from the market in the event of a recall.

This information was posted on the FDA Daily News itmes;Vol.4,No.221,Friday,Nov.9, 2007


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