-
es338 replied to the topic Thoughts and Questions Related to Untested Medicine in the forum Introduction to Project Management 7 years, 2 months ago
Acupuncture needles are regulated by the FDA, being classified as a Class II device. If the manufacturers of acupuncture needles claim treatments with their devices, then I believe the FDA would regulate the “therapy” or service differently than what is currently being done. Depending on the 510(k) submission, how a company legally markets their devices is done with incredible consideration in their promoting content. Acupuncture is considered a non-pharmacological approach for an alternative to opioid drugs. Below is a link to a FDA presentation about approaches taken/considered in resolving the opioid epidemic in the U.S..
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.5580