In brief
The Food and Drug Administration (FDA) has recently updated a number of regulations related to certain medical devices to ensure that they are carefully monitored and controlled, have prescribed quality standards, and are safe for consumers. The updated regulations relate to alcohol detecting devices, positive airway pressure (PAP) devices and dentistry devices.
In more detail
The FDA has recently updated a number of regulations related to alcohol detecting devices, PAP devices and dentistry devices. Some of the key issues that should be noted under the updated regulations, which have been issued under several Notifications of the Ministry of Public Health, are:
- Devices used to detect alcohol levels through body fluids and are used for medical purposes will continue to be classified as medical devices. However, breathalyzers used solely to detect alcohol levels without a medical purpose will no longer be considered medical devices.
- Sellers of PAP devices will now be required to obtain a medical device sales license from the FDA before they may sell PAP devices. Generally, sellers of PAP devices will only be able to sell PAP devices to consumers who have a prescription from medical professionals (i.e., doctors), though there are certain exceptions.
- Sellers of dentistry devices manufactured for dentistry or for use by dentistry professionals (i.e., dentists) (or under the supervision of dentists), as listed under the relevant notification (e.g., dental implants, orthodontic wires, clear dental aligners, dental filling materials, artificial teeth and fluoride varnish), will now be required to obtain a medical device sales license from the FDA before they may sell such dentistry devices. Sellers of these dentistry devices can also only sell them to medical facilities which are used for the conduct of the dentistry profession, dentists, or other persons who hold the medical device sales license. However, artificial teeth can only be sold to licensed manufacturers of dentistry devices.
The sellers of PAP devices and dentistry devices (as the holder of the medical device sales license) will be subject to additional obligations under the Medical Device Act and the relevant notifications.
For more information or assistance, please contact our Healthcare & Life Sciences and Regulatory Affairs Services team.
