[20180118]IF10813_医疗产品创新与监管：收益与风险 .pdf

https:/crsreports.congress.gov January 18, 2018Medical Product Innovation and Regulation: Benefits vs. Risks Prior to marketing in the United States, medical products are reviewed for safety and effectiveness by the Food and Drug Administration (FDA). Medical products regulated by FDA include prescription drugs, medical devices, and biologics. During the premarket review process, FDA balances the benefits that patients may receive from using the product against the harms or risks that some patients may experience. Brief History of Medical Product Regulation Congressional action to regulate medical products has often been in reaction to harm caused by an under regulated medical product. The Biologics Control Act of 1902 was the first attempt to regulate a pharmaceutical product at the national level. It was also the first premarket approval statute, in contrast to a retrospective postmarket product evaluation. The Biologics Control Act was passed in response to deaths, many in children, from tetanus contamination of smallpox vaccine and diphtheria antitoxin. The act focused on the manufacturing process and required that facilities be inspected before a federal license was issued to