Results 241 to 250 of about 454,812 (304)

Medical devices: US medical device regulation

Urologic Oncology: Seminars and Original Investigations, 2015
Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety of radiation-emitting ...
Jonathan P, Jarow, John H, Baxley
openaire   +2 more sources

Understanding medical device regulation

Current Opinion in Anaesthesiology, 2016
The purpose of this article is to provide a structural and functional understanding of the systems used for the regulation of medical devices in the USA and European Union (EU).Safe and effective anesthesia care depends heavily on medical devices, including simple, low risk devices to complex life-supporting and life-sustaining devices.
openaire   +2 more sources

Medical device regulation for manufacturers

Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, 2003
Manufacturers of medical devices are held to a higher standard than manufacturers of many other products due to the potential severity of the consequences of introducing inferior or unsafe products to the market-place. In Canada, the medical device industry is regulated by Health Canada under the Medical Device Regulations of the Food and Drug Act ...
P, McAllister, J, Jeswiet
openaire   +2 more sources

Regulation of Medical Devices for Dermatology

Dermatologic Clinics, 2022
Medical devices became subject to the current framework of regulation and premarket review by the Food and Drug Administration (FDA) in 1976. Devices are distinguished from drugs by the means in which they achieve their primary intended purposes. All medical devices, regardless of risk, share certain regulatory requirements to assure quality, safety ...
Shlomit, Halachmi, Laura, Marquart
openaire   +2 more sources

Medical devices regulations and the Medical Devices Agency

British Journal of Nursing, 2002
Pansy suffered from a chronic lung condition which required frequent courses of antibiotics. As her veins were poor and cannulation was difficult, a passport was inserted into a vein in her arm in which antibiotics and other solutions were administered.
openaire   +2 more sources

The Regulation of Wearable Medical Devices

Trends in Biotechnology, 2020
This article provides a guideline for the design, manufacture, regulatory approval, and post-market surveillance (PMS) of wearable medical devices (WMDs). The integration of regulatory considerations can accelerate wearable device (WD) development from laboratory to market while mitigating device failure risks.
Nan, Jiang, Julia E, Mück, Ali K, Yetisen   +2 more
openaire   +2 more sources

Legislation to Regulate Medical Devices

Biomaterials, Medical Devices, and Artificial Organs, 1975
The history of medical device regulation began with the need to rid the marketplace of bogus inventions which were either harmful in themselves or harmful because they delayed meaningful treatment of illness. Since World War II, sophistication in medical technology and development of electronic and other types of medical devices has created a new need ...
openaire   +2 more sources

Regulating incremental innovation in medical devices

BMJ, 2014
Patients need active regulatory oversight, linked to compulsory post-marketing research As therapeutic options, medical devices differ from prescription drugs in many ways, but one of the most important is their potential for rapid evolution in basic design or technology.
Aaron S, Kesselheim, Prashant V, Rajan
openaire   +2 more sources

Medical Devices — Balancing Regulation and Innovation

New England Journal of Medicine, 2011
The FDA approval system cannot assure the safety and effectiveness of increasingly complex medical devices. The Institute of Medicine has recommended eliminating a process that permits approval of a device based on its “substantial equivalence” to an existing device.
Gregory D, Curfman, Rita F, Redberg
openaire   +2 more sources

The Federal Regulation of Medical Devices

New England Journal of Medicine, 1987
BEFORE 1976, medical devices could be marketed without review by the U.S. Food and Drug Administration (FDA). Periodic attempts to regulate some devices as drugs for which the agency did require premarketing clearance proved to be cumbersome and inadequate.
D A, Kessler, S M, Pape, D N, Sundwall
openaire   +2 more sources