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OrthoLogic unapproved bone stimulators cited in warning letter are custom devices, firm claims.

This article was originally published in The Gray Sheet

Executive Summary

ORTHOLOGIC BONE STIMULATORS CITED IN WARNING LETTER ARE CUSTOM DEVICES and therefore do not require FDA approval via a premarket approval application supplement, the company has told FDA. In a May 31 warning letter, FDA charged that OrthoLogic "reconfigured" OrthoLogic 1000 bone stimulators for unapproved indications "without prior approval from the agency." OrthoLogic maintains that the products fit the definition of a custom device because they are manufactured in response to physician requests and are not generally available, kept in inventory or promoted for distribution. Custom devices are exempt from premarket approval requirements.



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