FDA Perspectives on Diagnostic Device Clinical Studies for Respiratory Infections
نویسندگان
چکیده
منابع مشابه
I-17: Failed Fertilization: from Molecular,Diagnostic and Clinical Perspectives
Low and/or total failed fertilization following ICSI is a disappointing effect that some couples may face during their treatment which may have severe social and economic consequences for these infertile couples. This phenomenon has been mainly attributed to failed oocyte activation post ICSI. Researchers have regarded this failure due to the absence or deficiency of sperm associated to oocyte ...
متن کاملInformed consent in clinical trials of in vitro diagnostic devices: perspectives from the FDA and manufacturers.
Editor’s Note: In view of current controversies in the US about informed consent for clinical studies of in vitro diagnostic devices, Associate Editor Fred Apple invited perspectives from the FDA and from two clinical scientists who work for manufacturers. The perspectives were peer-reviewed, revised, edited, and appear here. They add clarity to a topic that affects not only clinical chemists i...
متن کاملEpidemiological and clinical evaluation of children with respiratory virus infections
Background :Respiratory viruses are the leading cause of respiratory tract infections among children and are responsible for causing morbidity and mortality worldwide. This study was performed to detect viruses in children with respiratory infections and describe their epidemiology and clinical characteristics. Methods : In this descriptive cross sectional study, throat swabs and wash speci...
متن کاملStudies into viral respiratory infections
The primary objectives of the lecture are: (1) Describe the frequency and impact of viral infections and acute respiratory illnesses (ARI) among hospitalized patients and in the community; (2) Describe the analysis of respiratory viruses using in-house and commercial molecular diagnostics; (3) Estimate the effectiveness of influenza vaccination in the last two winters to prevent symptomatic inf...
متن کاملMining MAUDE: Human Factors Perspectives on EHR and Device Design from the FDA Manufacturers and Users Device Experience Database
Electronic Health Record (EHR) systems have been under development for several years, and have been in operational use by individual practices and healthcare delivery institutions since at least 2008. The federal Food and Drug Administration (FDA) maintains the Manufacturer and User Facility Device Experience (MAUDE) database to collect voluntary and mandatory reports of adverse events involvin...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Clinical Infectious Diseases
سال: 2011
ISSN: 1537-6591,1058-4838
DOI: 10.1093/cid/cir056