808 对州和地方医疗器械要求的联邦优先权的豁免 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS 809 人用体外诊断产品 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 810 医疗器械召回权 MEDICAL DEVICE RECALL AUTHORITY 812 试验用器械豁免 INVESTIGATIONAL DEVICE EXEMPTIONS 813 [...
808 对州和地方医疗器械要求的联邦优先权的豁免 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS 809 人用体外诊断产品 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 810 医疗器械召回权 MEDICAL DEVICE RECALL AUTHORITY 812 试验用器械豁免 INVESTIGATIONAL DEVICE EXEMPTIONS 813 [...
We started with the devices on FDA's List of Device Recalls,7 which includes only devices about which the FDA concluded “there is a reasonable chance that they could cause serious health problems or death.”7(p1) For each device on this high-risk recall list from 2005 through 2009, we ...
不良事件是指医疗器械使用过程中可能导致死亡、重大伤害、功能失常、不良反应等的事件。制造商需要及时向FDA报告与其医疗器械相关的不良事件,以便FDA监测和评估医疗器械的安全性和有效性。 医疗器械召回(Medical Device Recall):如果存在医疗器械可能存在缺陷、不安全或不符合法规要求的情况,制造商可能会主动发起召回行动。...
808 对州和地方医疗器械要求的联邦优先权的豁免 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS 809 人用体外诊断产品 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 810 医疗器械召回权 MEDICAL DEVICE RECALL AUTHORITY
This promptedthe recall of a non-sterile OTC liquid stool softener due to BCC contamination(Ref. 17). In a series of cases from 2000 to 2002, involving a medical device(an ultrasound gel), intrinsic contamination by BCC led to serious bloodinfections after the gel was used in association ...
808对州和地方医疗器械要求的联邦优先权的豁免EXEMPTIONSFROMFEDERALPREEMPTIONOFSTATEANDLOCALMEDICALDEVICEREQUIREMENTS（奥咨达医疗器械咨询） 809人用体外诊断产品INVITRODIAGNOSTICPRODUCTSFORHUMANUSE 810医疗器械召回权MEDICALDEVICERECALLAUTHORITY 812试验用器械豁免INVESTIGATIONALDEVICEEXEMPTIONS 813[预留的][Reserved] 814医疗...
FDA Implements Rule on Medical Device Recall AuthorityBiomedical Safety & Standards
810 医疗器械召回权 MEDICAL DEVICE RECALL AUTHORITY 812 试验用器械豁免 INVESTIGATIONAL DEVICE EXEMPTIONS 813 [预留的] [Reserved] 814 医疗器械的上市前批准 PREMARKET APPROVAL OF MEDICAL DEVICES 820 质量体系规章 QUALITY SYSTEM REGULATION 821 医疗器械跟踪要求 MEDICAL DEVICE TRACKING REQUIREMENTS(只专注于医疗器...
Thereview of voluntary recall actions during the same time period revealed over 50events associated with objectionable microbiologically contaminated NSDs12. Therecalls showed that a wide range of objectionable microorganisms were found ...