FDA规则:临床信息的收集,传输和管理.ppt
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1、Compliance with FDA Regulations: Collecting, Transmitting and Managing Clinical Information,Dan C Pettus Senior Vice President iMetrikus, Inc.,What does Regulation Mean?,For devices, drugs, etc., it means the manufacturer is held accountable for GMP and QSR under Title 21 parts 1 to 1299 (e.g., part
2、 801- Labeling, part 820 Quality System) Ability to electronically authenticate is permitted under 21 part 11 of the FDA regulations The FDA issued guidance documents which identify portions of title 21 part 11 as being applicable for clinical trials submissions,NOTE: Clinical Information may be reg
3、ulated by additional state and federal agencies. HIPAA is a good example.,Confused?,25 Years in technology development 20 Years in Healthcare Informatics When it comes to FDA (HIPAA, and others) regarding regulatory requirements for telemedicine and clinical data . and Im still confused?,A Device is
4、,According to the FDA, a device is: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any
5、 supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of
6、its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.“,If the primary intended use of the product is achieved through chemical action or by bei
7、ng metabolized by the body, the product is usually a drug. Human drugs are regulated by FDAs Center for Drug Evaluation and Research (CDER).,When is a device a device?,Diagnostic Patient Monitoring yes Electronic Medical Record Systems no? ICU Clinical Data Management Systems no? Anesthesia Data Man
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- FDA 规则 临床 信息 收集 传输 管理
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