FDA’s warning letters to device makers serve as vehicles for all kinds of statements, including statements about when a device maker needs a new regulatory filing. Lately it seems that has come up a lot more, but is that a trend or just a blip on the screen?
We all remember the outcome of FDA’s confrontation with Steris in 2009. The agency hammered the firm for a series of incremental changes to its System 1 sterilizers, and Steris eventually caved, withdrawing the sterilizer and filing a new 510(k). Since then, the pressure on the 510(k) program has been constant, but not unchallenged. The agency had to withdraw its ill-advised 510(k) changes draft guidance, but that’s not the only means by which FDA can regulate changes to class II devices, is it?
In any event, a good example of this is the agency’s June 6 warning letter to CareFusion of San Diego.* The found itself in hot water over its handling of particulate matter found in some devices, but FDA also had problems with changes in the materials used for two sets of devices. What kind of changes? The letter isn’t very specific on that score.
The June 12 warning letter to Spinal Elements included a discussion of changes to the company’s Lucent series of intervertebral fusion devices, but the citation seems reasonable to the untutored eye. FDA said the company had added some “bulleted” designs and changed the angle of curvature by five degrees in some of these implants.
Another June warning letter, this one dated June 11 to Smith & Nephew, dealt with a change to the filter used in the company’s Renasys negative wound pressure therapy systems. The interesting thing here is that the company undertook the changes to correct a problem with the previous filter, and apparently it worked. The company’s June 23 statement indicates it is working with FDA on the agency’s demand that S&N cease distribution, so it doesn’t sound like the company will have much trouble persuading FDA this is no big deal.
In sum, it’s perhaps asking a lot to extrapolate from this to a shift in how FDA goes after changes to 510(k) devices, but let’s see what happens between now and the end of the year. After all, this is three warnings all dated in the month of June.
(Edit: Within hours of the time I posted this, FDA announced in the Federal Register the final version of a 2011 draft guidance dealing with evaluations of substantial equivalence.)
The difference between what and what?
I know FDA gets tired of me picking at it, but the warning to CareFusion mentioned above includes one of the more peculiar findings I’ve ever seen in a warning letter. The letter states that CareFusion’s procedures for the medical device reporting form, known as form 3500A, was incorrectly described in the firm’s documents as “FDA Form 3500A: MedWatch Medication and Device Experience Report.”
FDA said the correct descriptor is “MedWatch Form FDA 3500A Mandatory Reporting,” but it strikes me as odd that the agency would make a point of saying so in a warning letter. FDA has in the past made a fuss over terminology such as “reasonably became aware of” adverse events, and one can understand how that might be important. But the title of a form is a big enough deal to say something in a warning letter?
Granted a search engine does not return the exact same results in precisely the same order for these two terms, but seriously, someone at FDA needs to lighten up. This is ridiculous.
* The URL for the CareFusion warning will change June 29, when the letter moves from the set of newly posted warning letters to the agency’s warning letter archive.