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.