What does FDA really mean when something is 510(k) exempt?

[Image by Chris Newmarker/MDO]

FDA undoubtedly provided some good news to the medical device industry last month when it proposed exempting hundreds of moderate-risk devices from 510(k) requirements. But don’t break out the champagne just yet if you happen to be developing a device that appears to be on the list.

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.

Get the full story on our sister site, Medical Design & Outsourcing.

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