Even when the agency says a particular generic device category is exempt from 510(k) requirements, it still places limitations on what type of devices inside the category can take advantage of the exemption, according to a new post on Hyman, Phelps and McNamara’s FDA | Law Blog.
Each classification regulation part (21 CFR Parts 862–892) has an often overlooked .9 section (e.g., 21 CFR § 862.9) that a device within a particular generic device type is exempt as long as its characteristics were “existing and reasonably foreseeable” at the time the exemption was made.
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