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The U.S. Food and Drug Administration (FDA) defines analyte specific reagents (ASRs) in 21 CFR 864.4020 as “antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended to be used in a diagnostic application for identification and ...
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1]
Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [1] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
At the same time the NB-MED (European Forum of Notified Bodies Medical Devices) coordination revised their code of conduct due to criticism. [ 7 ] [ 15 ] In late 2013 and early 2014, a French court ordered (and later upheld its decision) that notified body TÜV Rheinland pay restitution to those affected by the PIP scandal. [ 16 ]