Here is some background information to help you understand the complicated reclassification of equipment regarding which will affect machinery used for liposuction and ultrasonic liposuction for aesthetic reasons.The current proposal is long and complex but you may find it worth reading.
The FDA began implementing the Medical Device Amendments to the Federal Food, Drug & Cosmetic Act in 1976. The act gave the FDA the authority to regulate "medical devices."
Under the act the term "medical device" has very wide meaning. It includes any device in the official National Formulary used for diagnosis or treatment of disease or which is intended to affect the structure or any function of the body without chemical action . Many different products are therefore regulated as medical devices, for example wheelchairs, pacemakers and glucose test kits.
When a company makes these products they are regulated by the FDA. The amount of regulation is decided by the "Class" in which the device is placed by the FDA. There are three classes - Class I, II or III.
Based on class, there are three levels of control:
Class I devices: the lowest level of regulation is subject to the "General Controls" including good manufacturing, premarket notification, manufacturing site registration and device listing.
Class II devices: these are subject to the "General Controls" and in addition some "Special Controls" including labeling and a mandatory performance standards.
Class III devices: cannot be marketed until they have an approved Premarket Approval Application or (PMA), or because of Premarket Notification [510(k)] submissions the FDA finds they are substantially equivalent to pre-amendment devices.
Pre-amendment devices are devices which were marketed before May 28, 1976 and have been classified.
You can get more information from the FDA, ask for HHS Publication FDA 92-4222 , "An Introduction to Medical Device Regulations, U.S. Dept. Of Health and Human Services"
The ASPS (The American Society of Plastic Surgeons) also has a toll free number 1 800 635 0635 and can answer your questions or direct you to a spokesperson for the society. The Lipoplasty Society and the ASAPS are available to discuss this with you.
