The Food and Drug Administration (FDA) has warned Parcell Laboratories that it mischaracterized its stem cell-based bone regeneration product as a human cell, tissue and cellular or tissue-based product, when the product is actually a drug or a biologic and must conform to applicable regulations. According to a news source, Alphatec Spine has responded to FDA’s warning letter on behalf of Parcell, providing more information about its existing classification.
FDA contends that the product “is dependent on the metabolic activity of living cells for its primary function and is not intended for autologous use or allogeneic use in a first or second degree blood relative.” Alphatec Spine has responded with information about “how the product meets all of the criteria for being marketed under Section 361” (relating to human tissues or cells). The company’s PureGen™ Osteoprogenitor Cell Allograft, under development with partner Parcell, is apparently used in spinal fusion procedures. See Alphatec Spine News Release and Mass Device, July 25, 2011.