[20210929]IF11083_医疗产品法规：药物、生物制品和设备.pdf

https:/crsreports.congress.gov Updated September 29, 2021Medical Product Regulation: Drugs, Biologics, and DevicesThe Food and Drug Administration (FDA) regulates the safety and effectiveness of drugs, biologics, and devices (“medical products”) pursuant to its authorities under the Federal Food, Drug and Cosmetic Act (FFDCA) and the Public Health Service Act (PHSA). Drugs and devices are approved or cleared under the FFDCA, whereas biologics are licensed under the PHSA. Small molecule or chemical drugs are chemically synthesized, while biologics are derived from living organisms. All FDA-regulated medical products conceptually meet the definition of “drug.” Biologics are a subset of drugs, subject to many of the same regulatory requirements. A devicean instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related articlealso meets the definition of “drug”; however, unlike a drug or biologic, it “does not achieve its primary intended purposes through chemical action within or on the body . and is not dependent upon being metabolized for the achievement of its primary intended purposes” (FFDCA Section 201(h). FDAs Center for Biologic