Home | Collection | Chinese
Wechat/whatsup: 959750406666
Tel:184-6967-6785
E-Mail:2192346660@qq.com
QQ: 3453809991
Home About Us News Products Online Recruitment Download
Contact
  Product
  Disposable & Consumable
  Valve & Stopcock
  Extension Tube
  Casters & Wheels
  I.V. Infusion & Administration
  Lab & Sampling
  Connector & Caps
  Needles& Clips& Parts
  Instruments / Equipments
  Oxygen Concentrator
  Endoscopic Surgical
  Thermometer
  Monitors
  Infusion Pumps
  Weighing Scale
  Automatic Machine
  Radiology & Imaging
  CT MR DSA syringes
  CT MR DSA tubes
  Imaging Films, Pinters
  Injectors Machine
  Respiratory Pneumology
  Nebulizer & Tubes
  Filters / HME Bacterial
  Masks & Protective coveralls
  Ventilator / Anesthesia Machine
  Anesthesiology & ICU
  Anethetic
  Gynecology & Obstetrics
  Gynecology & Obstetrics
  Rehabilitation & First Aid
  Wheelchair
  Rehabilitation Support
  First Aid
  General Surgery
  Surgical pack
  Internal Medicine
  Interventional Cardiology
  Urology & Anorectal
  Hemotology
  Digestive Dept
  ENT Ophthalmology
  Orthopidics
  Pediatrics
  Stomatology
  Beautity
  Contact us
深圳艾克斯维医疗科技有限公司
联系人: 徐小姐
电话: 184-6967-6785
手机/whatsup/wechat:959750406666
QQ:2192346660
E-Mail: melissa.xu@x-waymedical.com
地址:深圳市龙华区龙华街道龙园社区龙华工业区498号
 

FDA Opens GUDID to the Public

FDA is building a medical device reference catalog through its Global Unique Device Identification Database, which it is opening to the public.

20150714001

FDA has opened the Global Unique Device Identification Database (GUDID) to the public. The database will serve as a reference catalog for every medical device with a unique device identifier, or UDI.

The public can download the entire database or certain parts through AccessGUDID, a portal created by FDA and the National Library of Medicine. They will not need a GUDID account. In this beta release of AccessGUDID, basic search and download functions are available, but there’s not much to search on yet. This first phase of a five-year rollout applies only to Class III devices.

Under the UDI final rule, the labeler of each medical device (in most instances, the device manufacturer) must submit information about that device to the GUDID, unless subject to an exception or alternative, the agency said. Single-use device reprocessors, convenience kit assemblers, repackagers, and relabelers are also considered labelers.

Labelers need a GUDID account to submit UDIs through the GUDID Web Interface or the HL7 SPL submission. Most devices will be required to have a UDI on their label and packaging, and for certain devices, on the product itself.

A UDI has two components:

A Device Identifier (DI) - A unique numeric or alphanumeric code specific to a device version or model.
Production Identifier(s) (PI) - Numeric or alphanumeric codes that identify production information. That can include the lot or batch number, serial number, expiration date, and manufacture date. For cell or tissue-based products regulated as devices, the distinct identification code also allows the manufacturer to associate the HCT/P to the donor. The public will only have access to the DI, the agency said.

Labelers had until Sept. 24, 2014 to submit UDIs for Class III devices. The labels of implantable, life-supporting and life-sustaining devices must bear a UDI by the same date of this year.

Making UDIs available on a database is one thing. Having them on payments from hospitals to Medicare and Medicaid is apparently another. Officials at the U.S. Centers for Medicare & Medicaid Services (CMS) apparently complained earlier this year that including such information would present too many technical hurdles and costs, according to The Wall Street Journal.

A study published in Heart Rhythm in 2011 supports the notion that the system would be costly for Medicare. Organized by University of Chicago and Northwestern University, the study scrutinized how a faulty Sprint Fidelis defibrillator lead from Medtronic was implanted in 268,000 patients before FDA pushed to remove it from the market. While UDIs would have helped manage the recall, the costs to Medtronic could fall between $287 million and $1.19 billion over five years, WSJ reported.

Officials at FDA and elsewhere have been touting a UDI system as a way to pinpoint problems with medical devices more quickly, and save lives. Advocacy groups in recent years claimed that recalled cars carry more identifying information than recalled pacemakers do.

Posted in Regulatory and Compliance by Nancy Crotti on May 5, 2015

Nancy Crotti

From Medtec News.

  links
  SHENZHEN X-WAY MEDICAL TECHNOLOGY CO. LTD   SHENZHEN X-WAY MEDICAL TECHNOLOGY CO. LTD
Home About Us News Products Feedback Jobs Download
Contact Us

SHENZHEN X-WAY MEDICAL TECHNOLOGY CO.,LTD Contact : Melissa Xu Wechat/WhatsApp:0086-136-3280-3610 Skype: melissaxu2013 Tel:+86-189 736 78487 Address:No.498 Longhua Industrial Road, Longyuan Community, Longhua Street, Longhua District, Shenzhen City, China


Click here to Send E-mail