FDA规则临床信息的收集传输和管理.pptxVIP

会计学1FDA规则临床信息的收集传输和管理 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 801- Labeling, part 820 – Quality System)Ability to electronically authenticate is permitted under 21 part 11 of the FDA regulationsThe FDA issued guidance documents which identify portions of title 21 part 11 as being applicable for clinical trials submissionsNOTE: Clinical Information may be regulated by additional state and federal agencies. HIPAA is a good example. 第1页/共13页 Confused?25 Years in technology development20 Years in Healthcare InformaticsWhen it comes to FDA (HIPAA, and others) regarding regulatory requirements for telemedicine and clinical data …. and I’m still confused?第2页/共13页 第3页/共13页 A Device is…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 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 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 being metabolized by the body, the product is usually a drug. Human drugs are regulated by FDAs Center for Drug Evaluation and Research (CDER). 第4页/共13页 When is a device a device?Diagnostic Patient Monitoring – yesElectronic Medical Record Systems – no?ICU Clinical Data Management Systems – no?Anesthesi