Results 21 to 30 of about 831,296 (284)
Integrating Failure Mode Effect Analysis into the Medical Device Approval Process [PDF]
, 2014 Medical devices that utilize computer software are becoming common place in today’s health care environment. Device failures can have life threatening consequences.
Kurniawati, Vania +2 more
core +1 more source
Correlation Between Conditional Approval and Customized Bone Implant Devices
Orthopaedic Surgery, 2019 This report aims to summarize key concerns regarding customized devices and conditional approval during the premarket evaluation of bone implants, and to explore the correlation between them.
Xiao‐lei Guo, Bin Liu, Zhong Lu
doaj +1 more source
Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices [PDF]
, 2011 Objective: To evaluate the FDA’s approval process and postmarket surveillance strategies for THR devices. Design: The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices.
Brennan, Troyen Anthony +4 more
core +1 more source
Are older people putting themselves at risk when using their walking frames? [PDF]
, 2020 Background Walking aids are issued to older adults to prevent falls, however, paradoxically their use has been identified as a risk factor for falling. To prevent falls, walking aids must be used in a stable manner, but it remains unknown to what extent ...
Baker, RD +8 more
core +3 more sources
FDA, CE mark or something else?—Thinking fast and slow
Indian Heart Journal, 2017 There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time,
Sundeep Mishra
doaj +1 more source
Journal of Clinical and Translational Science, 2023 Background:The Food and Drug Administration (FDA) reviews safety, efficacy, and the quality of medical devices through its regulatory process. The FDA Safety and Innovation Act (FDASIA) of 2012 was aimed at accelerating the regulatory process for medical
John T. Moon +6 more
doaj +1 more source
The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: Report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group [PDF]
, 2018 Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices.
Burnham, Carey-Ann D +6 more
core +2 more sources
Frontiers in Surgery, 2021 Background: In February 2009, the US Food and Drug Administration (FDA) granted Humanitarian Device Exemption (HDE) for deep brain stimulation (DBS) in the anterior limb of the internal capsule (ALIC) for the treatment of severely debilitating, treatment
Heather Pinckard-Dover +5 more
doaj +1 more source
Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]
, 2014 A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core +3 more sources
Regenerative Therapy, 2015 Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European ...
Kazuo Yano +5 more
doaj +1 more source