USA – FDA Floats Regulating Hyaluronic Acid Products as Drugs, Not Devices

The US Food and Drug Administration (FDA) intends to consider reclassifying hyaluronic acid (HA) intra-articular products intended for treatment of knee osteoarthritis as a drug rather than medical devices.

HA products for treating pain in knee osteoarthritis have been regulated as class III medical devices but the “current published scientific literature supports that HA achieves its primary intended purpose of treatment through chemical action within the body,” FDA explained in a notice issued on Monday. This intended use falls outside of the definition of a medical device under section 201(h) of the FD&C Act.

The current device classification is based on the understanding that HA’s primary intended purpose was achieved via mechanical actions, such as shock absorption, to a patient’s joint as it is introduced to the synovial fluid via inter-articular injection…