Results 11 to 20 of about 333,056 (304)
Drugs, Devices, and the FDA: Part 2
JACC: Basic to Translational Science, 2016 As with new drugs, the U.S. Food and Drug Administration’s approval process is intended to provide consumers with assurance that, once it reaches the market place, a medical device is safe and effective in its intended use.
Gail A. Van Norman, MD
doaj +4 more sources
Deep Brain Stimulation for Obsessive-Compulsive Disorder: Real World Experience Post-FDA-Humanitarian Use Device Approval [PDF]
Frontiers in Psychiatry, 2021 Background: While case series have established the efficacy of deep brain stimulation (DBS) in treating obsessive-compulsive disorder (OCD), it has been our experience that few OCD patients present without comorbidities that affect outcomes associated ...
Lora Kahn +6 more
doaj +2 more sources
GetMobile: Mobile Computing and Communications, 2019 Notary is a new design for a hardware wallet, a device that is used to perform sensitive transactional operations like cryptocurrency transfers. Notary aims to be more secure than past hardware wallets by eliminating classes of bugs by design and by formally proving the correctness of the key operation used in its implementation.
Athalye, Anish +4 more
openaire +5 more sources
JACC: Basic to Translational Science, 2016 The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible.
Gail A. Van Norman, MD
doaj +3 more sources
Medical Device Recalls and the FDA Approval Process [PDF]
Archives of Internal Medicine, 2011 Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device).
Diana M, Zuckerman +2 more
exaly +3 more sources
Review of approvals and recalls of US specific medical devices in general and plastic surgery
Surgery in Practice and Science, 2023 Background: Medical devices in the United States can be FDA approved either by the premarket notification (510(k)) or premarket approval process (PMA). Applications for PMA are more intensive than 510(k).
Aashka Shah +2 more
doaj +1 more source
Development of New Endovascular Devices for Aneurysm Treatment [PDF]
Journal of Stroke, 2018 Since the first use of the Guglielmi detachable coil system for cerebral aneurysm embolization in 1990, various endovascular methods have been developed to treat large numbers of aneurysms.
Zhen Yu Jia +8 more
doaj +1 more source
International Journal of Endocrinology, 2021 Objective. The objective of this article is to provide a high-profile review and discussion on the study design and statistical analysis of pivotal clinical trials conducted to demonstrate the safety and effectiveness of closed-loop investigational ...
Sravya B. Shankara +5 more
doaj +1 more source
Postmarketing Trials and Pediatric Device Approvals [PDF]
Pediatrics, 2014 BACKGROUND: Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate pediatric device development.
Hwang, Thomas +2 more
openaire +4 more sources
Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan
Frontiers in Medicine, 2022 Recently, there has been a growing trend in clinical development to utilize real-world data (RWD) to improve the efficiency of drug/medical device development.
Hideki Maeda +2 more
doaj +1 more source