FDA Adds 70+ Class I Medical Devices to List of Those Exempt from 510(k) Requirements

The notice published in the Federal Register on April 7, 2017 is summarized as follows: “The Food and Drug Administration (FDA or Agency) has identified a list of class I devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA’s final determination with respect to the class I devices included in this document. FDA’s action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.” Click here to read the notice, here for a story in RAPS Regulatory Focus and here for help with Pre-sub meetings with FDA, Quality Systems or 510(k) submissions.