Business · 18/12/2018

FDA to Reconsider Hyaluronic Acid Intra-articular Products for Knee Osteoarthritis Treatment

The US Food and Drug Administration (FDA) plans to review the classification of hyaluronic acid (HA) products used to treat knee osteoarthritis pain, considering whether they meet the definition of a medical device, and is urging sponsors to seek FDA jurisdiction determination before submitting a premarket approval application.