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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.
The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, and infant formulas). As of the summer of 2011, the program had received more than 40,000 adverse event reports. [1]
Summary of stated purpose: It provides reports usable by all parts of the CDF organization to analyze trends and improve service. The primary purpose was to comply with a regulatory requirement ( California Health and Safety Code Section 13110.5) intended to reduce costs and loss of life from fire and other events.
The FDA provides a database for reporting of adverse medical device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.
The California Department of Public Health (CDPH) is the state department responsible for public health in California. It is a subdivision of the California Health and Human Services Agency . It enforces some of the laws in the California Health and Safety Codes , notably the licensing of some types of healthcare facilities.
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
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RLDatix is a global enterprise software company offering software and services tailored to healthcare organizations. The technology platform is designed to support hospitals and other providers with risk mitigation, regulatory compliance, and workforce management resources.