How can a medical practitioner decide whether a medical device that they want to use for one of their patients is legal and approved by the Food and Drug Administration? When a patient comes into a physician’s office the patient is looking for the best, most modern care they can get. And a physician certainly wants the same thing.
This search for the best possible treatment presents a dilemma, however. How does the physician know what can be legally prescribed? When might the best treatment also be a treatment that is still in the process of being developed? When might a physician’s search for the most advanced treatment cross over into medical research, and where does FDA draw the line between the two. The answer is clear in some cases, but not so clear in others.
First let’s define what we mean by medical research. Research in the laboratory and on animals is usually called preclinical research. When a medical device has been successful in preclinical research the sponsor for a new medical device may apply to FDA for a Investigational Device Exemption (IDE) which, if approved, would allow for clinical research – research involving human subjects – to prove that the device is safe and effective on people.
When, and if, a device is approved by FDA, it is always approved for a particular set of indications for use. FDA does not approve a device for just any use.
If the physician is using a medical device strictly for the practice of medicine, then FDA does not get involved. That is a decision between the doctor and the patient. If, on the other hand the physician’s intent is to expand the indications of use of the medical device, then he is engaging in clinical research and must obtain an IDE approval beforehand.
Let’s look at an example. Recently there has been research that suggests that toenail fungus can be treated with laser. This is an interesting development because toenail fungus cannot be easily treated with either current internal or topical medicines. The fungus is typically encapsulated under the toenail.
As of this writing there is no laser that has been cleared for use in the treatment of toenail fungus. There are similar lasers, however, that have been cleared for dental use.
If a physician were to use the laser that had been cleared for dental use on an individual patient to treat a toenail fungus, this is called off-label use. There is a fine line between legal and illegal off-label use of medical devices. The difference lies in the intent when the physician uses or prescribes the medical device.
So how does FDA decide whether the physician is trying to expand the indications of use? If the physician is focusing only on what’s best for an individual patient, then he/she is free to pick the best treatment available. The physician should base his decision on the medical literature and his professional judgment of the risk versus benefit to that patient.
However, if the physician were to expand the practice to a number of patients or to publish the data, then FDA would interpret the work as performing clinical research and would require that the physician submit an IDE to FDA. If the work is being supported or advertised by the medical device company, that would be a clear red light.
If the physician is unclear whether a proposed procedure would fall into the category of clinical research he or she should consult the Institutional Review Board of the hospital where the work is being done.
For more information on this subject take VCI’s e-learning course Introduction to Medical Device Approval Pathways or call us at 734 274 4680.
Editor’s Note: Also published here.
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Norm Howe, Senior Partner at Validation and Compliance Institute, consultants for the pharmaceutical and medical device industries. He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA. He has held many management positions in FDA regulated industries, most at BASF. http://www.vcillc.com
Read more articles written by Norm Howe
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