Originally Published MD&DI June 2009
Washington Wrap-Up
The Five Rules of Custom Devices
What constitutes a custom device? The Endotec ruling reinforces that FDA’s custom device exemption regulation mirrors the Medical Device Amendments’ provisions that a custom device is one that
1. Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement to comply with the order of an individual doctor or dentist.
2. Is not generally available to, or generally used by, other doctors or dentists.
3. Is not generally available in finished form for purchase or for dispensing upon prescription.
4. Is not offered for commercial distribution through labeling or advertising.
5. Is intended for use by an individual patient named in the doctor or dentist’s order and is to be made in a specific form for that patient, or is intended to meet the special needs of the doctor or dentist in the course of professional practice.
Copyright ©2009 Medical Device & Diagnostic Industry
