The medtech industry appears to have won a round in the regulatory arena.
The FDA issued a final rule amending its regulations on classifying and reclassifying medical devices under the Food and Drug Administration Safety and Innovation Act (FDASIA), passed in 2012. Published today in the Federal Register, the rule says it “provides for the classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.”
When it was proposed in 2014, the rule drew comments from the industry arguing that the changes in definitions would result in more devices being classified into “burdensome, higher-class device categories, particularly into class III.” Other commenters said the changes would make class definitions too specific and narrow, particularly for class III devices. This could lead to “unwarranted reclassification of high-risk devices into lower classes,” the document says.