FDA Floats Regulating Hyaluronic Acid Products as Drugs, Not Devices

Regulatory NewsRegulatory News
| 17 December 2018 | By Ana Mulero 

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. Yet scientific literature published as recently as this year supports that HA mechanisms of action also include chemical actions, the agency’s notice elaborated.

At least 15 scientific sources, as cited in the notice, hold that HA may also act through chemical action to achieve its anti-inflammatory, analgesic and chondroprotective effects. These effects are believed to allow for HA to achieve its primary intended purpose as they act to mitigate the underlying condition.

The argument around chemical actions being the ones responsible for achieving the primary intended purpose of HA, as opposed to mechanical actions, also relates to the clinical therapeutic effect reportedly lasting for up to six months following injection. “In other words, treatment with HA has been reported to continue reduction in pain long after it is cleared from the knee joint,” the agency added.

FDA encouraged sponsors of HA products to first obtain a classification and jurisdictional determination via a pre- or request for designation (RFD) prior to a premarket approval application (PMA) or a PMA supplement for a change in indications for use, formulation or route of administration. Sponsors may provide evidence in support of their products meeting the medical device definition in a pre-RFD or RFD.



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