Wednesday, May 14, 2014

Warning Letter of The Week: Your Claims Are Too Big

From the FDA's recent warning letters:
Our review of the inspection and your firm’s websites ( and determined that the MegaVac System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
This letter gets only gets better (if not MUCH more textually NSFW), but I'm afraid I'm going to set off work firewalls cross the editorial boundaries of this blog, if I quote more.

Honestly, I did not intend for this feature to become a "naughty medical device of the week" thing, but, um, I cannot resist.  

1 comment:

  1. I feel a strange sense of satisfaction seeing a warning letter to medical device purveyors of that particular genre.

    Love these warning letters. Get a hoot out of them every time.