Tags
Consumer Reports, COnsumer Union, FDA, Food & Drug Administration, Medical device, UDI, Unique Device Identification, UNited States
FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments.
FDA Proposes Device ID Regulations for Medical Devices
CONTRACT MANUFACTURING, INDUSTRY NEWS
Unique device identification system will provide FDA with a critical tool for protecting patients.
The Food and Drug Administration (FDA) issued a proposed regulation 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,” states 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
Related articles
- Rottenstein Law Group Encouraged by FDA’s Proposed Rule Establishing a Unique Device Identification System (prweb.com)
- UDIs Required by the FDA (Draft for 120-day Review) – It’s about time! (13485cert.wordpress.com)
- Medical Device ” The Senate Passes Unparalleled Medical Device User Fee Act (earlsview.com)
- FDA proposes new device ID system to boost recall efforts, and patient safety (medcitynews.com)
- Consumers Union Urges Congress to Adopt Stronger Medical Device Patient Safety (clarksvilleonline.com)
- FDA Proposes IDs To Track Medical Device Safety (huffingtonpost.com)
- New FDA guidance on considerations used in device approval (earlsview.com)
- FiDA Failed Implant Device Alliance (earlsview.com)
- The Senate Passes Unparalleled Medical Device User Fee Act (depuyrecall.wordpress.com)
- Rottenstein Law Group Principal’s Opinion on FDA-Related Legislation Featured In Major Medical Device Publication (prweb.com)
Pingback: FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier « Earl's View
Pingback: FDA – User Fees for Medical Devices: Third Time Lucky? « Earl's View
Pingback: FDA to guide device makers on marketing application – chicagotribune.com « Earl's View
Pingback: Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions « Earl's View
Pingback: FDA to help medical device sales with expanded pre-market feedback program « Earl's View
Pingback: Medical Device ID Proposal Unveiled – GovInfoSecurity « Earl's View
Pingback: Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register « Earl's View
Pingback: Is the US Medical Device Industry Heading the Way of the Dinosaur? « Earl's View
Pingback: The US Medical Device Market is a Dinosaur – Mike comments « Earl's View