girlgeek33 wrote:Okay, I've heard of IRB and I get the process. But someone has just posted something that a hospital shut down a Doc in FL because the procedure is not FDA approved. This is the first I'm hearing that FDA is in the mix at all. Does FDA approve procedures such as this? I thought they were drugs & food. So I guess I want to understand. What happens after IRB and studies are done. Does the data collected go to the FDA? Do they decide if this is an acceptable treatment? What is the next step after a successful study?
1. the FDA is responsible for assessment and followup of all medications and devices. They do not approve procedures.
2. Devices used in la liberation include stents (hopefully infrequently) and balloons and catheters and drugs (contrast media).
3. devices are studied and receive approval for specific indications. Stents were originally approved for treatment of bile duct obstructions for cancers.
4. once a device is approved, a doctor may use it for other indications. for example biliary stents were used to treat atherosclerotic stenoses of blood vessels and angioplasty balloons (originally approved for arteries) were used in veins.
5. generally FDA does not get involved in such translation unless there are reported undo risks or complications or someone makes objection
6. hospitals can determine whether they want "off label" use of medications and devices.
7.payors may choose to withhold payment for off label use if it is not used as part of an IRB study
8. use by a doctor off label usually requires documentation of the need.
9. after a while and with sufficient paper publications, an off label use can become "standard of care'. Standard of care does not require IRB but of course any research, even on standard of care treatment requires irb supervision.
10. failure of a device requires reporting to FDA