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:9/28/2017)... 2017 Cohen Veterans Bioscience and Early Signal ... wearable and home sensors for real-time monitoring of patients ... a nonprofit organization focused on disruptive health solutions for ... analytical system to record and integrate behavioral, cognitive, physiological ... ...
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., ... vaccine design, and immune-engineering today announced the launch ... the development of personalized therapeutic cancer vaccines. EpiVax ... provided exclusive access to enabling technologies to the ... MBA will lead EpiVax Oncology as Chief Executive ...
(Date:9/19/2017)... a venture-backed medical device company developing a non-invasive, robotically assisted, platform therapy that uses pulsed ...   ... Jim Bertolina, ... Tom Tefft ... medical device executive Josh Stopek , PhD, who has led R&D and business development ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... , ... “America On The Brink”: the Christian history of the United States ... creation of published author, William Nowers. Captain Nowers and his wife, Millie, have ... thirty years in the Navy. Following his career as a naval aviator and ...
(Date:10/12/2017)... CA (PRWEB) , ... October 12, 2017 , ... ... Cheng, are now treating sleep apnea using cutting-edge Oventus O2Vent technology. ... a serious sleep disorder characterized by frequent cessation in breathing. Oral appliances can ...
(Date:10/12/2017)... Wis. (PRWEB) , ... October 12, 2017 , ... ... standard products to meet the demand of today’s consumer and regulatory authorities worldwide. ... of probiotic experts and tested to meet the highest standard. , These ...
(Date:10/12/2017)... MD (PRWEB) , ... October 12, 2017 , ... The ... of Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual ... – 8. , In honor of Morris F. Collen, a pioneer in the field ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... system that we intend to develop to enable prevention of a major side ... severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss is FDA ...
Breaking Medicine News(10 mins):