CFR 21-821 - Medical Device Tracking Requirements

These regulations implement the FDA's responsibilities for and authority over

1. Medical devices that are permanently implanted or life sustaining or life supporting
2. Any other device that the agency may designate

The FDA Modernization Act FDAMA removed the mandatory tracking requiement and limited FDA's discretionairt authority to require tracking only to class II and class III devices that are:

1. Reasonably likely to have serious adverse health consequences upon failure of the device
2. Intended to be implanted for over one year
3. Life sustaining or life supporting and intended for use outside a device user facility