- The Food and Drug Administration Approved it for Prescription Use
The FDA has approved the SoftWave device, specifically OrthoGold 100, as a Class 1 medical device that does not need its own premarket approval because it is substantially similar to a device that’s already FDA approved (the Dermablate Effect). The FDA only approved it for prescription use (not over the counter use). K182682-connective-tissue.pdf (softwavetrt.com).
Under the Code of Federal Regulations, a prescription-only medical device may only be used if, among other things, the device is “in the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device.”
- State Law Will Govern Who Can Prescribe it
Although federal regulations discuss who can prescribe prescription-only medical devices, state law generally governs this more specifically by outlining scope of practice for different practitioners. For instance, some states state that only physicians have prescriptive authority. Other states permit mid-level providers, like nurse practitioners and physician assistants, to prescribe in specific situations. One way to determine who can prescribe SoftWave is do review medical board meeting minutes to see if the medical board discusses SoftWave or similar devices.
State Laser Rules Could Apply
SoftWave is a shockwave device that uses ultrasound frequencies to penetrate muscles to improve healing. Some state laws may consider this under cosmetic/aesthetic laser rules. If your state has laser rules, the rules will likely define the types of lasers that fall under the rules. For instance, Georgia’s Cosmetic Laser Rules apply to light-based devices and “does not include devices which are not light based such as . . . ultrasound devices.” If SoftWave fall sunder your state’s laser rules, if applicable, be sure to follow those rules as well.
The above provides a limited overview of three considerations before introducing SoftWave therapy to your practice. There are may other considerations, such as your state licensing board’s stance and your insurer’s willingness to cover such services, as well as steps you can take to protect yourself and business. If you need assistance understanding the full realm of considerations governing SoftWave or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.