• Given that the FDA’s modus operandi is to keep life-saving treatments out of people’s hands, this is not surprising at all.

  • Now that Obamacare is law, just wait for the next shoe to drop, where we’ll see equally complex rules put in place for approval of new medical devices and treatments to qualify for coverage by insurance. And expect to hear of cases where the government orders medical devices to be withdrawn for months because some insurance qualification paperwork was done incorrectly, or because some new device doesn’t meet some cost-benefit analysis done by the government’s medical insurance czars.

  • There have been cases where makers of implanted devices have caused failure because they changed the manufacturing process in a way they thought would be okay but in the end wasn’t. Having requirements that the process be documented prospectively is reasonable. Otherwise the cause of the failure may be difficult to discover.

    OTOH requiring a recall for a product that was well manufactured with no known defects is unreasonable IMO.

  • In aerospace this is called configuration control. Boston changed the device without prior approval. Bad Boston (waggs finger at them). In my line of work that can have severe consequences. In medical devices the same applies. Unless and until a review is done no one knows of the now changed product meets requirements.

    That said, for the FDA to sit on their collective back sides when these devices are desperately needed is inexcusable. The response of the FDA is typical jerk petty official behavior. (slaps some sense into stupid FDA official, plants a boot firmly on their back side). Now get to work you effin lazy jerk and do the darn review.

  • What I don’t understand is, why not switch back to the already approved protocol until the paperwork is finished?

  • The question comes to mind – since I had one of the Boston Scientific devices implanted about 12 weeks ago – is “do they expect my surgeon to rip it out and replace it?” It’s not exactly a repossession, but government as repo man boggles the mind. Are we sure we want them running ALL of health care?

  • “no name guy” above relates the FDA to the FAA. Both agencies use procedure to improve safety But safety itself comes from neither agency, it comes from engineering. The FAA closes off competition from companies without size to support adequate development. A person starting as a pilot today is unlikely to have an engine problem in his career.

    The FDA is engenders excessive costs, reduces confidence in medical providers, and provides an opportunities for people to extort money, as in the Vioxx case. It is a failure in my opinion.