A search of the FDA website says that this is only the third warning letter ever issued by the FDA under a program to protect the public from the risks of clinical trials.
This enforcement action basically means that anyone doing CCSVI research will have to go through the same hoops drug and device manufacturers go through to prove in advance of research that their device is not likely to cause harm, something they do because they expect to make a ton of money on their approved device or drug.
If they hadn't classified venous angioplasty as a significant risk device, Dr. Mehta, and others, could have gone forward with their research as long as they noted that the devices (angioplasty balloons) were not specifically approved to treat extracranial veins of people with Multiple Sclerosis to an IRB. But by classifying it as a significant risk device, they force anyone who wants to study CCSVI treatment to get a specific exemption from the FDA, just as manufacturers do when they first start studying a new drug or device.
Their reasoning is buried in what is known as a 483 Form that they may or may not make public at some point. I am going to formally ask for that reasoning, but they don't have to answer me and probably won't.
It seems complete bullshit to say that venous angioplasty of extracranial veins qualifies as a "significant risk device" which they define this way:
(m) Significant risk device means an investigational device that:
(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
http://www.gpo.gov/fdsys/pkg/CFR-2011-t ... 1-vol8.pdf
So far, they have gone after Dr. Mehta. Don't be surprised when the FDA police start knocking on the doors of others doing research on CCSVI.
The neuros and pharma say that they can't support CCSVI without further research and they and their friends are now hell bent on making sure that research never happens.
And the FDA proves once again that they are great at protecting manufacturers from the public regardless of who is in the White House.