An overview of Food and Drug Administration regulation of drugs, biologics, and devices to be used for management of periodontal diseases.

Abstract

The Food and Drug Administration (FDA) has been actively involved in assuring the safety and effectiveness of medical products since 1906. The FDA was granted increased authority to regulate drugs in 1938 and devices in 1976. The regulatory requirements for marketing in the United States vary according to the type of product and the degree of risk associated with it. One route to the market is through the premarket notification [510(kappa)] process in which devices are evaluated according to their substantial equivalence to devices marketed prior to May 28, 1976. Many devices specifically intended to treat periodontal conditions have progressed through the 510(kappa) process based on their substantial equivalence to predicate devices. In some cases manufacturers have needed to provide clinical data in the form of Investigational Device Exemptions (IDE) to support an equivalence determination. Certain devices with indications for use in periodontal evaluation or therapy, specifically, those determined by FDA to be not substantially equivalent to legally marketed devices, require Premarket Approval Applications (PMA). For new drug products, clinical trials are carried out under an approved Investigational New Drug Application (IND). Application for approval for marketing is requested through a New Drug Application. Data from clinical trials conducted outside the United States may be considered by the FDA in support of the safety and effectiveness of the product. The FDA is continually developing and updating guidance documents and guidelines to assist manufacturers in gaining clearance/approval to market new products.