The Food and Drug Administration (FDA) has published draft guidance, called "Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements" (Draft Guidance).
The intent is to identify low-risk medical devices and exempt them from premarket notification requirements, i.e., 501(k) review. Specifically, the Draft Guidance signals FDA's intent to exempt certain Class I and Class II medical devices. The Draft Guidance includes a list of such devices.
Electronic comments to the Draft Guidance may be submitted to http://www.regulations.gov, and there is a method for submitting written comments. Comments are due by September 30, 2014.
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