TY - GEN T1 - Public health effectiveness of the FDA 510(k) clearance process : measuring postmarket performance and other select topics : workshop report A2 - Wizemann, Theresa M. LA - English PP - Washington, D.C. PB - National Academies Press YR - 2011 UL - https://ebooks.jgu.edu.in/Record/ebsco_acadsubs_ocn741137716 AB - "The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants."--Publisher's description OP - 118 CN - RA399.A3 P82 2011eb SN - 9780309162074 SN - 0309162076 SN - 1283134977 SN - 9781283134972 SN - 9780309215114 SN - 0309215110 SN - 0309162068 SN - 9780309162067 KW - United States. : Food and Drug Administration : Congresses. KW - United States : Food and Drug Administration KW - United States. : Food and Drug Administration KW - Public health : Equipment and supplies : Standards : United States : Congresses. KW - Public health : United States : Congresses. KW - Device Approval : standards KW - Device Approval : legislation & jurisprudence KW - Equipment Safety : standards KW - United States KW - Santé publique : États-Unis : Congrès. KW - HEALTH & FITNESS : Safety. KW - Public health KW - Congress KW - Electronic resource. KW - proceedings (reports) KW - Conference papers and proceedings KW - Conference papers and proceedings. KW - Actes de congrès. ER -