Navigation Links
FDA Proposes Unique Device Identification Regulations for Medical Devices
Date:7/3/2012

WASHINGTON, July 3, 2012 /PRNewswire-USNewswire/ -- The Food and Drug Administration (FDA) issued a proposed regulation today to establish a unique device identification (UDI) system for medical devices marketed in the U.S. A UDI system was mandated by Congress in 2007 but still is not in place.  Legislation passed by Congress in June requires the FDA to implement the UDI system for high risk, life sustaining and implantable medical devices within two years of finalizing the regulations.

Consumers Union, the policy and advocacy division of Consumer Reports, applauded the FDA for issuing the proposed regulations, while noting that it was still reviewing the draft rule.  Consumers Union will file formal comments to the proposed regulations later this year.   

"These regulations are long overdue and are critical for protecting patients from faulty and dangerous medical devices," said Lisa Swirsky, senior policy analyst for Consumers Union, the policy and advocacy division of Consumer Reports.  "Effective post-market surveillance of medical devices depends on having UDI in place.  Once it is fully implemented, this system will enhance the FDA's ability to identify problem medical devices more quickly and inform patients when their safety is at risk." 

For most medical devices, the UDI will include a device identifier, which is a unique code tied to a specific device model, and a production identifier, which includes production information for the device.  The FDA has proposed phasing in the implementation of the UDI system beginning with the highest risk medical devices first.  Low risk devices will be exempt from some or all of the regulations.  The FDA is seeking public comment on the proposed regulations for 120 days. 


'/>"/>
SOURCE Consumers Union
Copyright©2012 PR Newswire.
All rights reserved

Page: 1

Related medicine technology :

1. Fidelitas Launches Unique Methadone Documentation and Dispensing System in Canada
2. Unique Conference Tackles Opioid Abuse Epidemic
3. Cardinal Health, Detroit Medical Center, Henry Ford Health System Announce Unique Collaboration To Promote Urban Renewal
4. Quest Diagnostics Establishes Unique Healthcare Identifier to Improve Access to Vital Patient Health Information; 80 Million Patient IDs Created to Date
5. Upsher-Smith Research Shows Unique Pharmacokinetic Profile of USL255 Extended Release Topiramate
6. MarketsandMarkets: Global Ultrasound Devices Market worth $8.1 Billion by 2017
7. Boston Scientific Completes Patient Enrollment in PREVAIL Study for First-in-Class WATCHMAN Device
8. Global Electrodes for Medical Devices Industry
9. MarketsandMarkets: Global Radiotherapy Devices Market Worth $5.8 Billion by 2016
10. Distribution of C SAFE medical device for safer cesarean sections by preventing lacerations to newborns expands domestically and internationally
11. Quantum OPS Completes $1.05M In Series A Financing To Advance Surgical Devices
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... Research and Markets has announced the addition of the ... ... forecasts the global optical transceiver market to grow at a CAGR ... covers the present scenario and the growth prospects of the global ... report considers the revenue generated from the shipment of optical transceivers ...
(Date:12/9/2016)... Dec. 9, 2016  RxWiki Inc., a digital health ... marketing strategies of thousands of pharmacies through its Digital ... Austin Inno,s "50 on Fire" Award in the ... pleased to accept the award as one of Austin,s ... Executive Officer at RxWiki. "Our platform gives independent retail ...
(Date:12/8/2016)... 2016 IRIDEX Corporation (NASDAQ: IRIX ) ... of common stock, $0.01 par value (the "Offering" with such ...  The final terms of the Offering will depend on market ... can be no assurance as to whether or when the ... the net proceeds it will receive from this offering for ...
Breaking Medicine Technology:
(Date:12/8/2016)... ... December 08, 2016 , ... ... Medication Therapy Management (MTM), adherence, and other pharmacist-delivered patient care services, has announced ... counsel and Eric Hoessel to vice president of sales. , Litsinger joined ...
(Date:12/8/2016)... ... December 08, 2016 , ... Premier Fitness Camp (PFC) ... , the ultimate weight loss and wellness program, at their world headquarters of Omni ... provide immediate and long-term results to anyone seeking weight loss, personal development, a healthy ...
(Date:12/8/2016)... ... December 08, 2016 , ... STATEN ... been recognized for adherence to the highest standards of trauma, maternity, cancer and ... the center's president and CEO, Dr. Daniel Messina. , Among the recognitions, the ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... Care Act. Dr. Botelho advocates for the mass media launching of story movements ... ongoing opportunities to share their unfortunate experiences; such a movement can generate the ...
(Date:12/8/2016)... ... December 08, 2016 , ... The Dan Carlisle Agency, ... Jefferson County, is announcing the launch of a charity drive to raise support ... homeless women and children in Birmingham has grown steadily since the 1980’s, and ...
Breaking Medicine News(10 mins):