8.MAUDE database(制造商数据库) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM 9.Import Alerts (进口警报) https://www.fda.gov/industry/actions-enforcement/import-alerts 10.FDA's Recalls (FDA的召回) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm...
8.MAUDE database(制造商数据库) accessdata.fda.gov/scri 9.Import Alerts (进口警报) fda.gov/industry/action 10.FDA's Recalls (FDA的召回) accessdata.fda.gov/scri 11.483和警告信 fda.gov/AboutFDA/Center 12.Class I / II Exemption ( FDA 豁免的I类和II类设备) fda.gov/MedicalDevices/ 13.Med...
FDA Announces Improvements to Medical Device Recalls Databasedoi:10.1097/01.BMSAS.0000443194.01204.a3Biomedical Safety & Standards
Accessed November 9, 2010 FDA Recalls Not as Alarming as They Seem Archives of Internal Medicine Editor's Correspondence June 13, 2011 Medical Device Recalls: Get It Right the First TimeComment on “Medical Device Recalls and the FDA Approval Process” Archives of Internal Medicine Invited ...
Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and...
Toillustrate the importance of a microbiological risk assessment and controlstrategy, this guidance discusses incidents ofBurkholderia cepaciacomplex (BCC) and other microorganismcontamination in non-sterile dosage forms that resulted in ...
There wereeight recalls due to microbial contamination of alcohol or povidone-iodine preppads.患者术前备皮药品是局部消毒药物产品,用于在医疗程序或注射之前减少皮肤上微生物的数量,因为皮肤通常被微生物覆盖(参考文献 16)。其中一些产品不是作为无菌产品生产的(参考文献 16)。然而,已经有许多已发表的报告称,由于...
Retrieved from: https://www.fda.gov/medical-devices/consumers-medical-devices/learn-if-medical-device-has-been-cleared-fda-marketing U.S. Food and Drug Administration. (n.d.). Recalls, Corrections and Removals. (Devices). Retrieved from: https://www.fda.gov/medical-devices/postmarket-...
Voluntary Malfunction Summary Reporting Program 143 Eligibility and Scope 10 Consistent with this principle, summary reports submitted by manufacturers under the VMSR Program are made available to the public in the Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database is...
FDA有不少科学性实用性很强的指导文件、手册等等，须我们深入发掘。它还有一些链接信息资源非常广泛的站点，如Oncology Tools、Food Safety.gov、foodrisk.gov/等等，借此可以综览全美国欧洲许多信息。FDA和WHO不同之处在于前者提供的美国会员、药品信息、技术与研究、虽然我国良可借鉴，但因国情不同必须分析对待；后者...