Medical Devices: FDA's Implementation of the Medical Device Reporting Regulation : Report to the Chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, House of Representatives
What people are saying - Write a review
We haven't found any reviews in the usual places.
Other editions - View all
analysis Anesthesia machine assess blood glucose self-monitoring Breast prosthesis cardiac pacemakers causal Center officials conclusions Coverage and Compliance death or serious defibrillator device manufacturers device reporting regulation devices accounted early warning fda officials fda's follow-up frequently reported glucose monitors Heart valve hexokinase implementation Information Flow Infusion pump injury reports inspec inspectors Intraocular Lens Intrauterine device malfunction reports manufacturer or importer manufacturers and importers manufacturing practices mdr compliance inspections MDR Coverage mdr data base mdr inspections mdr problem reports mdr regulation mdr report processing mdr reporting requirements MDR Reporting System mdr system medical device firms medical device problem medical device reporting number of firms number of reports Office of Compliance Pacemaker electrode patient postmarketing surveillance pms potential reporters problem-reporting program prp procedures regulatory actions report disposition report processing system reportable events reported to fda reports received serious injury Structure and Process submitted to fda tion