FDA规则:临床信息的收集,传输和管理-精选文档.ppt
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1、What does Regulation Mean? nFor devices, drugs, etc., it means the manufacturer is held accountable for GMP and QSR under Title 21 parts 1 to 1299 (e.g., part 801- Labeling, part 820 Quality System) nAbility to electronically authenticate is permitted under 21 part 11 of the FDA regulations nThe FDA
2、 issued guidance documents which identify portions of title 21 part 11 as being applicable for clinical trials submissions NOTE: Clinical Information may be regulated by additional state and NOTE: Clinical Information may be regulated by additional state and federal agencies. HIPAA is a good example
3、. 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 According to the FDA, a devi
4、ce is: n“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: nrecognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, ninten
5、ded 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 nintended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purp
6、oses 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 If the primary intended use of the produc
7、t is achieved through chemical action or by being metabolized by the body, the product is usually a drug. action or by being metabolized by the body, the product is usually a drug. Human drugs are regulated by FDAs Human drugs are regulated by FDAs Center for Drug Evaluation and Center for Drug Eval
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