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:1/15/2014)... RAPIDS, Mich. , Jan. 15, 2014 As health ... the flu virus, select Meijer pharmacies in Michigan ... strep throat to eligible patients, enabling Meijer pharmacists to administer ... strict protocol set by a physician participating in the study. ...
(Date:1/15/2014)... , Jan. 15, 2014  Celsion Corporation (the "Company") (NASDAQ: ... received commitments from institutional investors to purchase an aggregate ... in an at-the-market registered direct offering, led by a ... into definitive purchase agreements with these investors pursuant to ...
(Date:1/15/2014)... 15, 2014  Humberto C. Antunes,  Galderma  worldwide CEO, will ... Journal of Drugs in Dermatology (JDD) at ... The event is January 17-20, 2014, at the Omni Orlando Resort ... The ODAC is a distinguished event that ...
Breaking Medicine Technology:Meijer Pharmacy Offers Free Flu, Strep Testing as Influenza Cases Rise Across the Midwest 2Meijer Pharmacy Offers Free Flu, Strep Testing as Influenza Cases Rise Across the Midwest 3Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 2Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 3Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 4
... positive,results from a Phase I trial of R1507, a ... in patients with solid,tumors. IGF-1 is one of the ... pathways, which promote cell growth and cell survival. The,IGF-1R ... role in mediating,the resistance to cytotoxic drugs and EGFR/HER2-targeted ...
... tolerated dose for trodusquemine determined, PLYMOUTH MEETING, ... ) today presented data from its dose-escalating,Phase 1 ... candidate for the treatment of obesity. In the ... clinical doses, and,no serious adverse events were seen ...
Cached Medicine Technology:Roche Announces Positive Results in Solid Tumors Using Human Monoclonal Antibody Against IGF-1R (R1507) 2Roche Announces Positive Results in Solid Tumors Using Human Monoclonal Antibody Against IGF-1R (R1507) 3Roche Announces Positive Results in Solid Tumors Using Human Monoclonal Antibody Against IGF-1R (R1507) 4Genaera Corporation Presents Phase 1 Data for Trodusquemine (MSI-1436) at the North American Association for the Study of Obesity Annual Meeting 2Genaera Corporation Presents Phase 1 Data for Trodusquemine (MSI-1436) at the North American Association for the Study of Obesity Annual Meeting 3Genaera Corporation Presents Phase 1 Data for Trodusquemine (MSI-1436) at the North American Association for the Study of Obesity Annual Meeting 4Genaera Corporation Presents Phase 1 Data for Trodusquemine (MSI-1436) at the North American Association for the Study of Obesity Annual Meeting 5
(Date:4/23/2014)... could help doctors predict which patients might suffer potentially ... The program, which assesses brain scans using pattern recognition ... passport control, has been developed by researchers at Imperial ... the Wellcome Trust, which used the software are published ... Stroke affects over 15 million people each year worldwide. ...
(Date:4/23/2014)... the United States, it may come as a surprise that ... food due to lack of money or other financial resources. ... University of Illinois using data from the National Health and ... dealing with hunger are also facing negative health and nutrition ... age 60 faced the threat of hungerthat translates to 4.8 ...
(Date:4/23/2014)... the journal Oncotarget , explored tumour heterogeneity ... their own DNA signatures within the same cancer. ... effective, targeted treatment strategies. , Firstly they confirmed ... either the KRAS or BRAF mutation. Secondly, they ... gene mutation have that specific mutation present uniformly ...
(Date:4/22/2014)... and industry leaders visited the New Jersey Institute ... Joel S. Bloom for the launch of the ... that provides a new model for business innovation ... education assets and investment. U.S. Senator Cory Booker, ... Joe Taylor, New Jersey Lieutenant Governor Kim Guadagno, ...
(Date:4/22/2014)... cancers are small cell lung cancers (SCLC), which ... However, researchers at Virginia Commonwealth University Massey Cancer ... leading to this resistance that may lead to ... mediating B-cell lymphoma 2 (Bcl-2) family proteins, which ... their function, this family of proteins can trigger ...
Breaking Medicine News(10 mins):Health News:Airport security-style technology could help doctors decide on stroke treatment 2Health News:Airport security-style technology could help doctors decide on stroke treatment 3Health News:More Americans in their golden years are going hungry 2Health News:Non-uniform genetic mutations identified in lung cancers could lead to targeted treatment 2Health News:Government and industry leaders herald launch of NJIT's New Jersey Innovation Institute 2Health News:Scientists pinpoint protein that could improve small cell lung cancer therapies 2
... MINNEAPOLIS, July 27 ATS Medical, Inc. (Nasdaq: ATSI ... today announced that it will release financial results for the second ... August 3, 2009. The Company will host a conference call ... Time (2:00 p.m. Pacific Time) to discuss its second quarter results ...
... ... ... 2009 -- Silver Creek Systems®, the pioneer and leader in automated Data Mastering, announced ... Management from Forrester Research, Inc., author Rob Karel recognizes the value the company delivers ...
... Midbrook is using ... use in hospitals and other medical facilities that are working to prevent infections. , ... (Vocus) July 27, 2009 -- Midbrook, ... case carts and storage cabinets has begun to use copper alloys as an alternative ...
... ... a large pill. Impact Nutritionals, Inc. launches its first product, S7 Prenatal™ Drink Mix, the ... premise that supplements should taste good and be good for you. To celebrate the launch, ... , ...
... ... in a state of crisis largely due to the failure of highly ... individuals. In his latest article, The Perfect Health Plan: Proven, Safe, Effective, ... occur per year from these FDA approved, properly prescribed, and properly administered ...
... Government health officials from 13 African countries today ... medical laboratories, starting a process that the World Health ... an historic step to strengthen health systems and lead ... of Africa,s laboratories are now accredited, in part because ...
Cached Medicine News:Health News:ATS Medical Announces Second Quarter 2009 Earnings Release Date and Conference Call 2Health News:Leading Independent Analyst Firm States Silver Creek Systems Holds A Virtual Monopoly In Delivering Advanced Product Data Quality Capabilities 2Health News:Midbrook Utilizes Copper in Medical Environments 2Health News:Moms, Registered Dietitian, Develop the First All-In-One Prenatal Vitamin in a Great Tasting Drink Mix 2Health News:Research Scientist Reports On Time-Tested Solution To Current Medical Crisis 2Health News:Research Scientist Reports On Time-Tested Solution To Current Medical Crisis 3Health News:Research Scientist Reports On Time-Tested Solution To Current Medical Crisis 4Health News:Leading health organizations launch new accreditation process for laboratories across Africa 2Health News:Leading health organizations launch new accreditation process for laboratories across Africa 3Health News:Leading health organizations launch new accreditation process for laboratories across Africa 4
... IV and the Penilab V have an exceptionally sensitive ... is similar to the Model 1061 shown below, but ... added later. The Penilab V has a Doppler. ... accessories you'll need to get started. Latex rubber ...
... is designed for vascular labs already ... Its primary use will be ... a cuff with air. Blood ... cuffs - a proximal occluding cuff ...
... With its outstanding optical performance, the ... light used for all types of applications. ... micro-lens technology complies with the highest standards ... provides excellent shadow control within the surgical ...
... The DRE-200 ESU units use dedicated digital ... for processing data. This hardware allows parallel ... processing throughput, measuring tissue impedance 5000 times ... processed digitally, being converted to analog only ...
Medicine Products: