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:10/22/2014)... , Oct. 22, 2014  Charlene Vernak, RPh, of ... , recently was awarded the George Roentsch Scholarship ... received the award in Houston ... scholarship is awarded annually to an independent pharmacist and ... of George Roentsch , a well-known pharmacist in ...
(Date:10/22/2014)... , Oct. 22, 2014 Moms are ... health trackers for themselves and their kids, according to ... Report: Health & Fitness Go Mobile for Moms, the ... Series. BabyCenter, the number 1 pregnancy and parenting web ... that 55 percent of moms surveyed say they can,t ...
(Date:10/22/2014)... SAN DIEGO , Oct. 22, 2014 ... II medical device received 510 (k) OTC clearance by ... the AVACEN 100 to be marketed over the Internet ... with arthritis; muscle spasms; and minor strains and sprains ... The AVACEN 100 (MSRP $2495) is a ...
Breaking Medicine Technology:PCCA Awards Charlene Vernak, RPh, the George Roentsch Scholarship 2BabyCenter Finds Mom Ready to Live the "Measured Life" in its U.S. Mobile Mom 2014 Report: Health & Fitness Go Mobile for Moms 2BabyCenter Finds Mom Ready to Live the "Measured Life" in its U.S. Mobile Mom 2014 Report: Health & Fitness Go Mobile for Moms 3BabyCenter Finds Mom Ready to Live the "Measured Life" in its U.S. Mobile Mom 2014 Report: Health & Fitness Go Mobile for Moms 4AVACEN Medical Announces FDA Clearance of First Medical Device with Internal Game Mode 2
...  Leading events organiser UBM Live has revealed further ... Pharma Portfolio, CPhI Southeast Asia (SEA) 2012. Set to debut ... Indonesia, CPhI SEA is the first trade show and exhibition ... sector in the ASEAN region. CPhI SEA ...
... Conn., April 18, 2012   A new retrospective ... rates of intracranial hemorrhage (ICH), including both fatal and ... taken twice daily compared with warfarin. Results of the ... Journal of the American Heart Association. ...
Cached Medicine Technology:Leading Pharma Ingredients Event Debuts in Growing ASEAN Market 2Leading Pharma Ingredients Event Debuts in Growing ASEAN Market 3New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 2New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 3New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 4New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 5New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 6New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 7
(Date:10/22/2014)... 2014 Although there are only 24 hours in ... people who have trouble finding time within their busy schedules for ... long periods of time to get in shape. Here are five ... the go. , Change Up Your Commute , Consider riding ... add some exercise into your daily routine. If you must use ...
(Date:10/22/2014)... 2014 Akeso Biomedical, Inc. , ... treatment of bacterial infections, microbial biofilms, and chronic wounds, ... board of directors. , Dr. Sinskey ... The Massachusetts Institute of Technology, or MIT. He has ... Dr. Sinskey also holds positions as Co-Director of the ...
(Date:10/22/2014)... Two sisters in high school have developed ways to ... Krishen use electronic stethoscopes, which electronically amplify body sounds, ... or heartbeats. Ilina, a senior at Port Huron ... way to detect early lung damage in people exposed ... recorded one breath cycle each from 16 smokers, 25 ...
(Date:10/22/2014)... News) -- Measures taken by Firestone officials at the ... have limited the spread of the disease there and ... Natural Rubber Co. provides health services to about 80,000 ... populated communities. Between Aug. 1 and Sept. 23, ... those 80,000 people. That incidence rate of 0.09 percent ...
(Date:10/20/2014)... 20, 2014 The newly updated Worldwide ... of thousands of facts, figures and forecasts on the ... medical sector forecast categories the Worldwide Medical Market ... and national views on the worldwide medical market to ... report gives you data for 2010-2019, covering each country ...
Breaking Medicine News(10 mins):Health News:HealthGuideMD Presents Ways to Improve Your Exercise and Fitness 2Health News:Akeso Biomedical Appoints Dr. Anthony J. Sinskey to Board of Directors 2Health News:Teen Sisters Develop Ways to Measure Lung, Heart Damage 2Health News:Tire Company Sets Standard for Ebola Care in Liberia: CDC 2Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 2Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 3Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 4
... provide its comprehensive preventive care web service to STHS members and ... and motivate individuals to improve their health and safety. , ... ... a new partnership with eDoc4u , all eligible members and ...
... First Annual Diversity Council Honors Award(TM)RIDGEFIELD, Conn., ... top honor from the Association of Diversity ... Council Honors Award(TM). The award recognizes the ... diversity council groups that lead diversity processes ...
... Xevo TQ and Synapt HDMS Mass Spectrometers Target ... April 1 Waters Corporation (NYSE: ... Institute,s Center for Cancer Research in Bethesda, Md., ... and Waters ACQUITY(R) UPLC/Xevo(TM) TQ MS Systems for ...
... (AVP) receptor antagonist now available in new premixed ... Pharma US, Inc. today announced the commercial availability ... injection) Premixed in 5% Dextrose, a new premixed ... arginine vasopressin (AVP) receptor antagonist, is the first ...
... Eyecare Professionals Advise Diabetics on How to Minimize That ... Organization reports that 366 million cases of diabetes are ... because of the risk posed to healthy sight by ... Optical, Inc. reveals a dangerous lack of awareness about ...
... a drug took the fun out of stealing, would it ... 1st issue of Biological Psychiatry , published by Elsevier, ... is a type of impulse control disorder characterized by persistent ... an irresistible urge to steal items they often don,t even ...
Cached Medicine News:Health News:Nashville's eDoc4u Signs Partnership Agreement With Saint Thomas Health Services 2Health News:Nashville's eDoc4u Signs Partnership Agreement With Saint Thomas Health Services 3Health News:Boehringer Ingelheim Recognized For Diversity And Inclusion Efforts 2Health News:Waters Corporation Announces the Purchase of UPLC/MS Systems by the National Cancer Institute for Advanced Metabolomics Research 2Health News:Waters Corporation Announces the Purchase of UPLC/MS Systems by the National Cancer Institute for Advanced Metabolomics Research 3Health News:Astellas Launches Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia 2Health News:Astellas Launches Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia 3Health News:Astellas Launches Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia 4Health News:Lack of Awareness of Eye Health Risk Associated with Diabetes Poses Blinding Threat to Millions 2Health News:Lack of Awareness of Eye Health Risk Associated with Diabetes Poses Blinding Threat to Millions 3Health News:Lack of Awareness of Eye Health Risk Associated with Diabetes Poses Blinding Threat to Millions 4Health News:Suppressing the compulsion to steal 2
Carl Zeiss immersion oils are PCF free. They are quality controlled for two wavelengths of light, Ne=1.518 and Nd=1.515 at 23ºC....
Immersion oils may crystallize on storage. Can be redissolved on heating to 50ºC (1-2 hours)...
... Oils are the standard - the ones to ... Laboratories has consistently led in the development and ... Here is the record: , When the FDA ... of In Vitro Diagnostics in the 1970's, Cargille ...
... an Informatics software product enabling quick and ... the laboratory. With SpecTRACK Software, users can ... specimen from all laboratories in their LAN ... or cold room. Automate your existing manual ...
Medicine Products: