The Medical Device Daily Perspectives blog is finally back, and we’d like to thank everyone on the IT team at ThomsonReuters for restoring the blog. I’ve always had the feeling that anyone in the IT business probably feels like salt-water taffy at a toddler’s birthday party: They’re constantly getting pulled in a dozen different directions, and we MDDers would like to thank them for standing us back up.
But now we’re back and our first target after the layoff is, of course, FDA. The agency published a very intriguing item in the March 25 Federal Register, which might not have attracted as much attention as it merits. Following are two passages I thought were interesting.
FDA’s stakeholders have suggested that premarket and postmarket controls typically associated with class III devices, such as requiring clinical trials to provide an independent assessment of the safety and effectiveness of a device, can be established as special controls.
In other instances, FDA’s stakeholders have suggested that all high risk devices should be classified in class III, even if those risks are well understood and may be able to be controlled through premarket studies showing equivalence to a marketed device, labeling, and other general or special controls.
Note that the agency remarks that “stakeholders have suggested.” That has the ring of “the Devil made me do it,” but is it really just so much saber rattling?
Maybe, maybe not. I’m of the view that federal agencies don’t go around adding comments like that to an FR notice strictly for the purpose of draining a barrel of virtual ink. Beyond all that, I’d also point out that those who rattle sabers have sabers, and it’s best not to pretend they’re unarmed.
Another passage of interest states that FDA has often had a tough time scheduling an inspection of a facility within the 90 days allotted for a 510(k) review “on the rare occasions that FDA has required a manufacturing inspection.”
The agency then states that should it find that an inspection of the manufacturing facility “is necessary to provide RASE [a reasonable assurance of safety and effectiveness] for a potentially high-risk device, general and special controls are inadequate to provide RASE and thus the device meets the statutory definition of” a class III device.
The notice does not come out and say “if we want to inspect your place before clearing your device and you don’t make it happen, you need a PMA rather than a 510(k).” That certainly seems the implication, though. This passage addresses devices deemed “potentially high risk devices,” a piece of language some may find remarkably elastic.
There’s much more in there, but I have only one thing more to say. It sure is good to be back in the blogosphere!