Last week, the FDA announced it would not require manufacturers to alert the agency when changes are made to a device unless the change poses a safety risk. Who gets to decide that? The manufacturer!
Historically, a medical device manufacturer had to create an FDA 806 report to signify if it planned to change a device and that change could represent a potential risk to health.
Under this new guidance, medical device changes that qualify as “enhancements” will not require an 806 report.
In fairness to device makers, they may want from time to time to “enhance” or improve their product. Maybe adding a blue stripe down the center of transvaginal mesh would make it more visible when a doctor is trying to remove the product. A device may need to be improved to better measure the presence of antigens in the blood. Steel used in a guide wire may need to be replaced with a better quality steel.
Generally speaking, these changes had initiated a recall, if the agency knew about it, but now manufacturers can bypass the 806 report if the “enhancement” doesn’t jeopardize safety.
Manufacturers are big on seeking out the “least burdensome” regulatory oversight. The 510(k) approval process is a prime example. Under 510(k) paperwork is exchanged so a manufacturer can market their device on the fast-track with no clinical trials required.
There is no doubt what’s least burdensome to industry has proven most burdensome to consumers who had no idea that the FDA was hands-off requiring assurances for safety and efficacy of devices under 510(k), and now under a lessened 806 requirement.
So this latest guidance is in line with the agency’s hands-off approach to device makers.
On November 5, the FDA will conduct a webinar with manufacturers to answer any questions.
It’s very “least burdensome” to avoid any scrutiny by the FDA and that is exactly what happened when Johnson & Johnson launched its Prolift vaginal mesh kit for the treatment of pelvic organ prolapse. Even though there had never been a large piece of mesh pre-cut complete with implanting devices prepackaged, J&J just started selling the device. It was only when, three years later, it asked the FDA to approve the Prolift +M did the FDA know anything about the original device. There were no sanctions, no penalty and the agency simply approved both the Prolift and Prolift +M at the same time in 2008.
In handing over device regulation to the very companies it oversees, the FDA is expecting all to self-regulate according to the rules.
FDA: Distinguishing Recalls from Medical Device Enhancement, October 15, 2014
Workshop November 5, 2014
FDA Least Burdensome Standard