FDA Authorities Clause Samples

FDA Authorities. The FD&C Act grants FDA authority to regulate devices as defined in 21 U.S.C. 321(h). Under section 321(h), the term "device" includes an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory that is intended to cure, mitigate, treat, or prevent disease in man, or is intended to affect the structure or any function of the body of man. Liquid chemical germicides intended for use in conjunction with a variety of articles that fit within the statutory definition of "device," such as operating instruments, medical examining tables, hospital scales, and other hospital equipment, also fall within the definition of "device" because they are considered accessories to these devices. Unless liquid chemical germicides used in conjunction with devices were commercially distributed prior to May 28, 1976,1 manufacturers of these products, under 21 U.S.C. 360(k) [section 510(k) of the FD&C Act] are required to submit a premarket notification to FDA before they market their products. Before these products can be legally marketed, FDA must grant marketing clearance by (1) issuance of an order in response to a section 510(k) submission which exempts the device from the FD&C Act's premarket approval requirements, or (2) approval of a premarket approval application. In granting marketing clearance by issuance of a section 510(k) order exempting a liquid chemical germicide from premarket approval, FDA must find that the device is "substantially equivalent," as the term is defined in 21 U.S.C. 360c(i)(1)(A), to a predicate device that does not require premarket approval. Section 513 of the FD&C Act authorizes FDA to exempt products from premarket notification requirements for which there is a reasonable assurance of safety and effectiveness. At present, no chemical germicides that are used with devices have been exempted from premarket notification requirements. In regulating liquid chemical germicides used with devices, FDA is exercising its responsiblilities under the FD&C Act for ensuring that devices are safe and effective for their intended uses. The FD&C Act provides enforcement authority to FDA to pursue regulatory actions, including seizure, injunction, prosecution, and civil penalties.