We live in an interesting time. Those we grant the power to create Law also grant power to others to regulate. We will often say, “It’s the Law”, when in reality ‘it’s the Regulation’. Either way we have a responsibility to abide by those regulations or to see that they are changed. What we do not have a right to do is ignore them.
With that said, we have a rash of regulations that effect the dental industry now which were not around several years ago. I do not pretend to know them all or to council you on them, but… I can send you to the statutes and let you decide where you fall. In the dental laboratory industry we used to say that we fell under the Doctors Responsibility Umbrella, that is, the Doctor bore the judgmental portion, which decided whether a specific product or manufactured part are used with a patient, and we, as just a Laboratory manufacturer, were “off the hook”. More than likely that was not so true then, but it is especially not true now!
Of the products we manufacture, we need to know which Medical Device Class they represent (Class I, II or III) and what the regulations are which surround them. Then we need to make sure that we are following those regulations. I have attached the link to the FDA, which regulates us and you can follow through with Title 21, Chapter 1, Subchapter H, Part 872 (Dental Devices), Sub Part D (Prosthetic Devices). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1
Remember that if you are getting into “Sleep” devices you will need to be very specific about what you are trying to accomplish. The regulations are complex for you and for your Dentists. Dentists in most States are not to Diagnose APNEA. This is the purview of the Physician. Therefore, you must know the State Dental & Medical Boards regulations on this matter before you start supplying APNEA devices to your clients who are not supposed to be issuing that diagnosis in the first place!
I would suggest that you have some advice on what you are doing. In our industry that is the NADL (www.NADL.org) and commercially, SAFE LINK Consulting (www.safelinkconsulting.com).
Make sure that you are following the Law and the Regulations!