This article has been updated with comments from the FDA. A recent JAMA Internal Medicine editorial takes another swipe at the FDA for delays in improving its medical device adverse-event reporting. Journal editor Dr. Rita Redberg and Dr. James Salazar, both of Department of Medicine, University of California, San Francisco, note several instances in which […]
Unique Device Identifier (UDI)
The middle of 2017 is shaping up to be a continued whirlwind of activity for medtech. FDA is getting used to its new leadership but is facing a continued lack of clarity on user fees and UDIs. Industry is seeing a deeper consolidation in medical supplies, exemplified in Cardinal Health’s purchase of patient recovery supplies from […]
Labelers of class I and unclassified devices recently got a reprieve when FDA announced an extension of the compliance date for unique device identification (UDI). Makers of devices such as manual surgical instruments and mechanical wheelchairs will have 2 extra years to get these devices submitted to the Global unique device identification database (GUDID), FDA announced last […]
The Centers for Medicare & Medicaid Services is on board with plans to create a unique device identifier for implantable medical devices, after years of resistance from the federal health insurer. CMS had balked at implementing the FDA’s UDI program because of the cost and difficulty of integrating UDIs into electronic health records. Congress enacted the UDI law […]
Makers of contact lenses and intraocular lenses are getting a 1-year reprieve after the FDA agreed to shift their due date for complying with Unique Device Identifier rules.
Manufacturers successfully lobbied for a delay after demonstrating that requirements for lenses would create a massive burden for both device makers and regulators.
The FDA issued a pair of new documents this week outlining the agency’s thinking on review of breakthrough medical devices and providing guidance for small companies trying to keep up with the new Unique Device Identifier program.
In a draft guidance proposed today the FDA offered some advice for companies developing novel devices that they believe are low-risk and thus eligible for more lenient review.
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have issued a draft notice on plans to implement a national Unique Device Identification (UDI) system based solely on guidelines developed by the International Medical Device Regulators Forum (IMDRF).
The FDA today released the final version of its guidance regarding the new unique device identifier program, a new mandate that requires certain medical devices to have coded labels that make them trackable via a national database.
U.S. regulators issued a finalized rule that encompasses prior guidances into a single document, providing the final rules on the global UDI database, advice for initial submissions and other elements of the program.
Deadlines are fast approaching for medical device makers to unveil their Unique Device Identifier compliance programs and, if last year’s survey results are any indication, many companies are unprepared.
When PricewaterhouseCoopers surveyed more than 300 industry participants last year, less than 1 in 5 said they were prepared for UDI implementation and 19% said that they had not even started planning their UDI programs.
Incoming AdvaMed chairman Jose Almeida has an international outlook, planning to focus his 2-year leadership tenure on several goals that aim to reconcile initiatives in the U.S. with efforts overseas.