UDI Milestone: Unique Identifiers Now Required For Class III Devices – But Are Some Firms Lagging Behind?

UDI Milestone: Unique Identifiers Now Required For Class III Devices – But Are Some Firms Lagging Behind?-thegraysheet: FDA’s Unique Device Identification system finally passed arguably one of its most important milestones on Wednesday: Makers of high-risk medical devices are now required to add distinctive barcodes to product labels. Manufacturers were also expected to enter product identifiers into a global UDI database by FDA’s Sept. 24 compliance deadline – a task that some firms are still struggling to complete, industry insiders say.

Pew Tells Senators UDI System Will Promote Health Data Sharing

Pew Tells Senators UDI System Will Promote Health Data Sharing-thegraysheet: In response to the Senate Finance Committee’s June 12 request for comments (Word Document) on ways to make health care data more useful and readily available, stakeholders behaved like characters in the “Blind Men and the Elephant” fable, i.e., each group commented on totally different aspects of data sharing issues. The Senators wrote: “Health care-related data, specifically, is a growing but largely untapped resource for accelerating improvements in health care quality and value.” The committee asked providers, patients, advocates, insurers and industry for new ideas to improve the overall transparency of the health care system. Comments were due Aug. 12.

HHS Pushes To Incorporate UDIs Into Electronic Health Records

HHS Pushes To Incorporate UDIs Into Electronic Health Records-thegraysheet: Developers of electronic health records may be pushed to capture unique device identifiers for implantable medical devices in their systems under a proposed rule issued by the HHS Office of the National Coordinator for Health Information Technology.

Update on US FDA Unique Device Identification Submission System

Update on US FDA Unique Device Identification Submission System-massdevice: Manufacturers with US medical device market authorization are required to submit device identification data into a Global Unique Device Identification Database (GUDID) managed by the FDA. Firms now have two options for submitting information to the GUDID: a GUDID Web Interface that requires users to set up GUDID accounts, and an HL7 SPL option for submitting device information via xml file one record at a time.

FDA Hopes Not To Repeat Exchange Portal Glitches With UDI Database

FDA Hopes Not To Repeat Exchange Portal Glitches With UDI Database-insidehealthpolicy: FDA plans to launch a global database to store Unique Device Identifier information in 2014 but is being careful about how it "rolls out" the database given technical issues plaguing other federal websites, according to an agency official. The agency has no idea how many people will use the database or how many devices will be registered to the site and would like to be sure that it has the bandwidth needed to ensure the system works smoothly, said Jay Crowley, senior advisor for patient safety in FDA's device center. He added, however, that the staggered compliance deadlines for UDI implementation  should help the agency address any issues.

FDA Considers Reducing UDI Direct Marking Requirements For Implants

FDA Considers Reducing UDI Direct Marking Requirements For Implants-thegraysheet: Jay Crowley, FDA’s senior advisor for patient safety and the lead official on the developing UDI program, provided an overview of some of FDA plans for the upcoming final UDI rule during a May 1 session at the Medical Device Conference, co-sponsored by FDA and Xavier University in Cincinnati. The proposed rule was released last July, and FDA received more than 250 comments, some of which made convincing arguments for changes, Crowley said.

FDA's next-gen medtech surveillance bets heavily on unique device identifiers

FDA's next-gen medtech surveillance bets heavily on unique device identifiers-massdevice: The FDA laid out plans to revamp its postmarket surveillance of medical devices, and a large part of that has to do with finalizing and implementing a long-awaited Unique Device Identifier program to better track and monitor devices.

FDA To Issue UDI Database Draft Guidance In March

FDA To Issue UDI Database Draft Guidance In March-graysheet: The draft guidance will serve as a user’s guide to the soon-to-be-released unique device identifier database, providing definitions for the device elements and attributes that companies have to submit to the database.

FDA: Don’t Rely On Device Labeling To ‘Design Out’ Product Risks

FDA: Don’t Rely On Device Labeling To ‘Design Out’ Product Risks-thegraysheet: Manufacturers shouldn’t make the mistake of using product labeling to mitigate device risks, according to a recent FDA draft guidance. Instead, firms should “design out” those risks to ensure that they only make quality products, an agency official says.

Device History Record Oversights A Clear Path To Quality Troubles

Device History Record Oversights A Clear Path To Quality Troubles-thegraysheet: Device history records that do not include labeling, signatures on documents and dates of product manufacture are just a few of the problems that may cause FDA to dig deeper during facility inspections.

FDA Pushes Device Surveillance Plan That Could Involve PCORI; Off-Label, Data Access Debated

FDA Pushes Device Surveillance Plan That Could Involve PCORI; Off-Label, Data Access Debated-InsideHealthPolicy.com:
FDA device officials are pushing for a national postmarket surveillance monitoring system that emphasizes Unique Device Identifiers and their incorporation into electronic health records, device registries, modernized adverse event reporting and new methods to analyze postmarket information, laying out the plan in a paper released late last week and discussed at a public meeting Monday (Sept. 10).

FDA outlines postmarket surveillance plan ahead of public meetings

FDA outlines postmarket surveillance plan ahead of public meetings-massdevice.com:


Ahead of a 4-day public meeting blitz, the FDA released a preliminary proposal for strengthening medical device post-market surveillance.

FDA to host Florida conference on long-awaited UDI program

FDA to host Florida conference on long-awaited UDI program-massdevice.com:
FDA regulators invite device makers, GPOs and other healthcare industry stakeholders to a Florida conference on medical device unique device identifiers.

FDA announces public workshops for medical device tracking system - MassDevice

In an effort to increase the amount of post-market surveillance of Class II and Class III medical devices, the FDA is going ahead with their plan to examine the creation of Unique Device Identifiers.

FDA announces public workshops for medical device tracking system - MassDevice: "The FDA announced open registration for a series of workshops on the 'adoption, implementation, and use of unique device identifiers (UDIs) in various health-related electronic data systems.'"