Our healthcare and business law firm works with many providers and medical practices to ensure compliance with state and federal laws, rules, and regulations for given procedures, treatments, and prescriptions. Providers have differing opinions on the use and efficacy of certain treatments. One such treatment is Ozone therapy. This blog post outlines considerations prior to introducing Ozone therapy to your medical and wellness practices’ offerings. If you need assistance understanding the full realm of considerations governing ozone therapy 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.
- Consider the Food and Drug Administration’s Regulations
21 C.F.R. 801.415 is a regulation of the Food and Drug Administration (“FDA”), which provides: “Ozone is a toxic gas with no known useful medical application in specific adjunctive, or preventative therapy.” Further on the regulation provides: “A number of devices currently on the market generate ozone by design or as a byproduct. Continue reading ›