The Food and Drug Administration (FDA) released a final order on Friday, classifying autofluorescence detection devices for use during surgery as Class II devices, the intermediate regulatory category.
The Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act established three regulatory classes for medical devices. The three classes, per the agency, are based on the degree of control necessary to assure the various types of devices are safe and effective. Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices, like elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. Class II devices include powered wheelchairs and some pregnancy test kits. Class III devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury, like pacemakers and breast implants.
Statutorily, most medical devices are initially classified as Class III, then as more information is collected the devices receive a de novo classification to a lower level of concern. Devices are classified into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use.
The decision was prompted by AiBiomed, Corp.’s request for de novo classification of the Parathyroid Detection (Model PTeye) System, as well as a similar request from Fluoptics for the Fluobeam 800 Clinic Imaging Device.
