I recently blogged about stem cell applications and it is prudent to discuss an issue that applies to any new medical technology and advancements. The question is: “when can I as a medical provider, introduce new technology, especially if it is not yet FDA cleared”?
This is a very important question. The answer is difficult and there are never any guaranteed correct answers. The law in the USA is typically a moving target. For one thing, the law necessarily lags behind technology (in every aspect of technology – not just medicine). However, medicine is a bit different because we have the FDA to protect patients and provide a process for clearing products and services for treatment. The problem is that it is a time consuming process.
This discussion starts with the fact that the FDA does not have jurisdiction over physicians. It regulates devices and products and the claims that may (or may not) be made about them. The FDA cannot interfere with the physician’s “independent medical judgment”. Accordingly, physicians are free to utilize a product or a device in a manner that they believe will prove beneficial for a patient. They must uphold their Hippocratic Oath to “do no harm” and clearly, the physician should be able to indicate and articulate why the treatment or procedure was performed on a patient.
A physician should study the science and if he or she reasonably concludes that this treatment or product will benefit the patient within the physician independent medical judgment, then it may be acceptable to perform the treatment or procedure. It would also be beneficial to illustrate that peers are doing it as well to help indicate a standard of care for the particular use.
The problem with a new, non-FDA cleared treatment is the marketing of it. The internet has made it easier for patients to find you but it has also made it easier for the FDA to find you! It is tricky and difficult to market new technology, but as I am known to say, “There is always a way!”