Certainly I'm not a lawyer. So when I received this inquiry about Cutera selling in violation of FDA guidelines, I decided to post it here on the main page and see what the thoughts around it are.
Are Cutera, Palomar, Cynosure, Alma, and the rest of the IPL and laser technology companies violating the FDA's guidelines for selling medical devices to non-physicians? Does anyone care? Should non-physicians be able to own an IPL, cosmetic laser, or Thermage unit? Is this more about protecting a market or patient safety?
Happy to have Cutera respond.
via email from T:
I have read this blog for over a year and a half and have been interested in the business and legal aspect of this industry.
There are many issues which intrigue me but a couple areas that stand out are: 1.) The legality of sale of prescription medical devices to "business people" and 2.) How laser companies such as Cutera are double dipping and hurting doctors business through their unethical sales practice… as well as violating FDA regulations with regards to selling prescription medical devices to business people under the guise of the use of a "medical director".
First, I know first hand that Cutera is selling prescription medical devices to business people directly. As you know the FDA clearly states with regards to medical devices:
Medical Devices: Purchasers of medical device items hereby certify and assure that such items will be used or resold only under the conditions specified below:
Medical device items are subject to the laws and regulations administered by the Food and Drug Administration (FDA). Provisions of the governing statute, the Federal Food, Drug and Cosmetic Act appear in 21 U.S.C. 331, et. seq . In summary, the Act prohibits the movement in interstate commerce of medical devices that are misbranded or adulterated. The Act authorizes FDA to initiate criminal enforcement proceedings against companies and/or individuals responsible for violations of its provisions. Moreover, the Act authorizes FDA to initiate civil proceedings to seize, or enjoin the distribution of such items. Prescription devices are subject to additional Federal, state and other applicable laws. Federal law requires that prescription devices be in the possession of either persons lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device, or practitioners licensed by their state. Federal law also requires that prescription devices be sold only to or on the prescription or order of a licensed practitioner for use in the course of his or her professional practice, and that the devices are labeled in a specific manner. Refer to 21 CFR 801.109.
The area underlined above states the obvious and is in direct contrast to this “medical director” concept used by companies such as Cutera. I have a copy of Cutera “medical director” form and no where does a doctor neither signs the form nor put their license on the form for the purchase of these devices.
These “medical directors” don’t own the business, the lasers are not used in the course of their professional practice” and yet Cutera and other laser companies continue to sell these devices in this manner.
This leads into my second point. As this is happening, it increases competition to “legal” laser clinic and medical offices that have the authority to own and operate these prescription devices. These laser companies are selling their prescription devices to their “core customer base”, physicians and then turning around…even in the same town and selling to “non-physicians and increasing competition. As well, the AAD and other medical organizations allow these companies to display and exhibit at medical meetings. This is sickening.
It would seem to me that a site that is committed to the success and professionalism of the spa industry, such as medicalSpaMD could shed some light on the sale practices by the laser companies. You do a great job telling people how to run and market their clinics but if you really want to make a difference and help your fellow physicians succeed, it would helpful to eliminate the “illegal” practice and competition being perpetrated by laser companies.