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:10/11/2017)... , Oct. 11, 2017  True Health, a ... amplified its effort during National Breast Cancer Awareness ... cancer risks. ... Oncology calculated that more than 10 million American ... mutations in BRCA1 or BRCA2 and have not had ...
(Date:10/10/2017)... Pa. , Oct. 10, 2017   West ... in innovative solutions for injectable drug administration, today shared ... West,s ID Adapter for improving the intradermal administration of ... Fourth Skin Vaccination Summit in May 2017 by Dr. ... Lead, Polio Department, World Health Organization (WHO), and recently ...
(Date:10/4/2017)... Korea , Oct. 4, 2017  South Korean-based ... next-generation CPR training aide "cprCUBE" on Kickstarter. The device ... compression during cardiac arrests with better efficiency compared to ... also offers real-time feedback on efficacy of the compression ... crowdfunding campaign has a goal to raise $5,000. ...
Breaking Medicine Technology:
(Date:10/13/2017)... Worth, TX (PRWEB) , ... October 13, 2017 ... ... financial planning agency serving communities in the greater Dallas, Miami, and Raleigh regions, ... young boy fighting to overcome a rare and deadly chromosome abnormality. , After ...
(Date:10/13/2017)... ... October 13, 2017 , ... The American Board of Family Medicine's (ABFM) Board ... Chief Executive Officer, succeeding Dr. James C. Puffer upon his retirement. Dr. Newton will ... Dr. Puffer’s retirement at the end of 2018. Upon assuming the role of President ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of the ... a national organization of elder law and special needs planning attorneys. “Membership in ElderCounsel ... also provides a forum to network with elder law attorneys nationwide,” said Somekh. ...
(Date:10/13/2017)... ... , ... Ellevate Network, the leading network for professional women, brought together some ... at their inaugural Summit in New York City in June. The event was livestreamed ... over 3 million. To watch the Mobilize Women video, click here . ...
(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
Breaking Medicine News(10 mins):