A lot of warning letters and other FDA enforcement action are addressed to obscure companies, but lately a few big names have come under scrutiny. In a recent posting here at MDD Perspectives, we addressed a warning letter to Edwards Lifesciences, but they’re not the only big name to show up behind the FDA woodshed.
Is this a trend or mere chance? I’ll let you decide.
FDA recently posted the 483 from an inspection of Intuitive Surgical of Sunnyvale, California, which is not unheard of, but is not exactly routine practice, either. 483s basically condense the inspectional findings into bullet points and hence the text looks a lot like what you’d see in a warning letter, which is what we might expect Intuitive to find in its mailbox soon.
The company and FDA got into it over the firm’s promotion of an indication of thyroidectomy for the da Vinci surgical robot, and the FDA investigator bootstrapped that finding into one for design controls. The biggest story, however, was the matter of intra-surgical cleaning of instruments used with the da Vinci, which is apparently linked to some of the electrical discharge issues associated with patient injury. This, in turn, has driven at least some of the recent rash of litigation against Intuitive.
FDA told me that it will post 483s or other documents upon receipt of three or more requests filed under the Freedom of Information Act. I wonder who filed for the 483. Could there be a liability attorney in there somewhere?
Maybe, but anyone in the device business knows better than to play games with intended use or indications for use. Seriously, folks, Sheriff Jeff Shuren is on the job. Did you not get the flyer?
Medtronic, the Minneapolis-based giant that started out in someone’s garage, might not regret its purchase of Italian device maker Invatec in 2010, but FDA told Medtronic chieftan Omar Ishrak that the Diver and Amphirion catheters would be stuck in port pending corrections at the Invatec plant in Roncadelle, Italy. Despite the detention threat, Medtronic indicated the two catheters will still be available in the U.S.
One of the citations in the May 6 warning letter states that Invatec and Medtronic failed to report a recall of the Diver catheters, but it’s not clear what the recalls were about. Medtronic indicated that nothing in the warning letter requires clinicians to do anything, so the recall in question might be nothing more than some change to the instructions for use.
FDA really needs to fix this recall terminology problem. It’s been dangling out there for years and years, and given all the hoopla over the 510(k) program and the deluge of guidances coming out of the agency, you would think they’d have done something about this one word by now.