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The Medical Device User Fee and Modernization Act (MDUFA) authorizes the Center for Devices and Radiological Health (CDRH) to collect user fees from medical device manufacturers. [1] It is reauthorized every 5 years.
As the AMA decided in April 1960, the Current Medical Terminology (CMT) handbook was first published in June 1962 – 1963 to standardize terminology of the Standard Nomenclature of Diseases and Operations (SNDO) and International Classification of Diseases (ICD), and for the analysis of patient records, and was aided by an IBM computer. [22]
Every medical treatment facility should have policies and processes on equipment control and asset management. Equipment control and asset management involves the management of medical devices within a facility and may be supported by automated information systems (e.g., enterprise resource planning (ERP) systems are often found in U.S. hospitals, and the U.S. military health system uses an ...
Primary Care Case Management (PCCM) is a system of managed care in the US used by state Medicaid agencies, in which a primary care provider is responsible for approving and monitoring the care of enrolled Medicaid beneficiaries, typically for a small monthly case management fee in addition to fee-for-service reimbursement for treatment. [1]
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
In health care, diagnosis codes are used as a tool to group and identify diseases, disorders, symptoms, poisonings, adverse effects of drugs and chemicals, injuries and other reasons for patient encounters. Diagnostic coding is the translation of written descriptions of diseases, illnesses and injuries into codes from a particular classification.
Additionally, quality management system requirements for manufacturing a software medical device, as is the case with any medical device, are described in the U.S. Quality Systems Regulation [25] of the FDA and also in ISO 13485:2016.
Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury, is to be subject, premarket approval to provide reasonable assurance of its safety and effectiveness.