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.
“Determining whether or not a device’s characteristics (i.e., fundamental technology and intended use) were foreseeable at the time of the exemption is not an easy task, and is rather subjective,” said Hyman, Phelps and McNamara associate Allyson Mullen in the blog post.
So when would a .9 section cause you to still have to seek a 510(k) clearance? The .9 regulation does elaborate. A 510(k), for example, would be needed if the intended use is different from the generic device type. On the flip side, a 510(k) would also be required if the “fundamental scientific technology” is different.
Mullen in her FDA | Law Blog suggests that device developers examine pre- or post-exemption 510(k) clearances to get an idea of whether device might also still require a clearance.
If there are no 510(k) clearances out there to provide a guide, then it’s a matter of determining whether intended use and scientific technology has changed enough to warrant a 510(k), despite the exemption. Mullen suspects even a modest intended use change could trip the exemption, while the bar for fundamental scientific technology changes appears to be high.
FDA is set to finalize its list of proposed 510(k) exemptions in July.
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