Effects of the Medical Device User Fee and Modernization Act on Fda Review Times for Medical Devices

2018 ◽  
Author(s):  
Eric Sun ◽  
Kelly M. Ferguson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Device User ◽  
User Fee

scholarly journals MDUFA and its Impact on Medical Device Sector

2020 ◽  
Vol 11 (2) ◽  
pp. 2109-2116
Author(s):  
Anjana B ◽  
Naga Gouri T ◽  
Pramod Kumar T M ◽  
Venkatesh M P
Keyword(s):  
Medical Device ◽  
Review Process ◽  
Approval Process ◽  
Patient Health ◽  
Device User ◽  
User Fee ◽  
Set Up ◽  
Short Time ◽  
To Receive ◽  
The U.S

The U.S. Congress passed Medical Device User Fee Act (MDUFA), where FDA is required to assign and collect fees from manufacturers of medical devices to evaluate the functioning and the usage of the device.  for the purpose of fastening the analysis of the application of the drug. The Medical Device User Fee Modernization Act was first adopted in 2002. The act focussed on innovative review process and reviewing capabilities of experts. Every five years, MDUFA comes up with reauthorisation. The act was reauthorized in 2007 by reducing the application fee and introducing certain new fees such as the annual product fee and annual establishment fee which helped in pre-market evaluation. Few issues being raised in MDUFA II led the congress to enact an amendment. The next revision of the act made the review process more efficient and interactive with the applicant to meet the timelines. Recent amendment has set up several new performance goals and proposes certain changes to the previous amendments. The device manufacturers are currently in a position to receive regulatory approval in a short time compared to the pre-MDUFA period. MDUFA has helped in improving the patient health by streamlining the FDA’s approval process for application of new medical device, thereby allowing patient’s quicker access to potentially life changing therapies.

How to Program Positive Medical Device User Experience Using Narratives, Storytelling and Priming

2016 ◽  
Vol 5 (1) ◽  
pp. 89-93
Author(s):  
Thomas Koester ◽  
Hanne Salling Kierkegaard ◽  
Jeanette Juul Jakobsen ◽  
Nils Toft ◽  
Christian Bang
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Control Experiment ◽  
Control Group ◽  
Psychological Outcome ◽  
User Experiences ◽  
Device User ◽  
Randomized Control ◽  
Experimental Group ◽  
Narratives And Storytelling

This study investigates how narratives and storytelling in relation to the delivery of a medical device to a patient influence the psychological effect of the device on the patient. The effect was investigated in a pilot study designed as a randomized control experiment in which an experimental group was exposed to positive narratives and storytelling in delivery of cosmetic breast enhancing surgery. The control group went through the same surgical procedures but without hearing these positive stories. Results show that the experimental group reported significantly more positive user experiences than the patients who were not exposed to the stories. It is concluded that narratives and storytelling enhance a positive psychological outcome and that more research in this area could help design the delivery of medical devices to patients.

scholarly journals An updated review on Materiovigilance for safe use of medical devices

2020 ◽  
Vol 8 (4) ◽  
pp. 5-13
Author(s):  
Mansi Deshwal ◽  
Manju Nagpal ◽  
Gitika Arora Dhingra ◽  
Geeta Aggarwal
Keyword(s):  
Adverse Events ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
Current Status ◽  
Future Directions ◽  
Holistic Understanding ◽  
Device User ◽  
The Subject ◽  
Reporting Data

In the last two decades, there has been an upsurge in the volume of medical devices and thereby increasing medical device-related adverse events. So, materiovigilance is an essential system for identifying, collecting, reporting and analysing adverse events related to medical devices. The Vigilance programme for the medical device was initiated in many countries many years ago but, is a quite new concept for India. The Materiovigilance programme in India was launched on July 6 2015, at the Indian Pharmacopoeial Commission (IPC) with the objective of monitoring adverse events, thereby reducing risks related to use of medical devices and also creating awareness among different stakeholders for improving patients’ safety. The intent of this review article is to provide holistic understanding of medical device related adverse events; classification, reporting criteria, what, where, how, who and why, timeframe and tools used for reporting. Data collected using various search engines and compiled to give complete information regarding the subject matter. The thorough understanding of current status of materiovigilance programme in India including challenges involved in the programme and future directions for improving has been stated. Case studies have been reviewed for Johnson & Johnson’s faulty hip implant and Medtronic premature battery depletion. Implementation of Materiovigilance programme of India (MvPI) version 1.1 lead to safeguard the health of device user by preventing recurrence and risk associated with medical device.

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