منابع مشابه
FDA Regulation of Medical Devices and Medical Device Reporting
There are three main stakeholders in medical device regulation: people in industry, regulators and practitioners. A medical device report is filed after a device-related adverse event occurs. Studies show that while most medical device reports begin with practitioner observations, people in industry file 97% of reports and practitioners file 3% of reports. The objectives of this article are to ...
متن کاملFDA: reuse of single-use devices.
Additional news items in this issue: Eradication ofMRSA From a Health Center Ward and Nursing Home, page 334; Intra-abdominal VRE Infections: The New Threat, page 346; Serratia Outbreak From Contaminated Pressure-Monitoring Equipment, page 356; New Guidelines for Design and Construction of Hospitals, page 362; CDC Issues Infection Control Guidelines for Hemodialysis Centers, page 369; Transmiss...
متن کاملSecurity and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance
BACKGROUND Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. METHO...
متن کاملReview of the processes for FDA oversight of drugs, medical devices, and combination products.
In the United States, drugs and medical devices are regulated by different divisions of the U.S. Food and Drug Administration (FDA). While defined similarly, drugs and medical devices differ in their modes of action. Both are products that are labeled, promoted, or used in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. A device, ho...
متن کاملHospitals worry about new FDA proposal for medical devices: technical complexities of labels could compromise utility.
A proposed FDA rule on unique device identification could complicate billing and bar-coding procedures for hospitals.
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: JAMA
سال: 2014
ISSN: 0098-7484
DOI: 10.1001/jama.2013.286274