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Unique Device Identifier (UDI)

JAMA editorial slams FDA over adverse-event reporting

January 9, 2020 By Nancy Crotti

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 […]

Filed Under: Cardiovascular, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: FDA, JAMA Internal Medicine, Medtronic, stjudemedical, Unique Device Identifier (UDI)

Here are the top 5 medtech stories of mid-2017

June 23, 2017 By Heather Thompson

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 […]

Filed Under: Business/Financial News, Diabetes, Digital Health, Food & Drug Administration (FDA), Mergers & Acquisitions, Regulatory/Compliance Tagged With: Apple, Apple Watch, BD, becton dickinson, C.R. Bard, Cardinal Health, Dexcom, FDA, Medtronic, spectrumplastics, UDIs, Unique Device Identifier (UDI)

FDA extends UDI compliance date for low risk devices

June 5, 2017 By Heather Thompson

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 […]

Filed Under: Food & Drug Administration (FDA), Health Information Technology, News Well, Regulatory/Compliance Tagged With: FDA, UDIs, Unique Device Identifier (UDI)

Medicare gets back on board with unique device identifier

July 15, 2016 By Brad Perriello

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 […]

Filed Under: Wall Street Beat Tagged With: Centers for Medicare and Medicaid Services (CMS), Unique Device Identifier (UDI)

Report: Medicare balks at implementing FDA’s unique device identifier

March 11, 2015 By Brad Perriello Leave a Comment

Report: Medicare balks at implementing FDA's unique device identifier

The Centers for Medicare & Medicaid Services is reportedly balking at implementing the FDA’s unique device identifier program because of the cost and difficulty of integrating UDIs into electronic health records.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Centers for Medicare and Medicaid Services (CMS), Dept. of Health & Human Services (HHS), Unique Device Identifier (UDI)

FDA delays UDI rule for contacts, intraocular lenses

August 20, 2014 By Arezu Sarvestani Leave a Comment

FDA delays UDI rule for high-risk contacts, intraocular lenses

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.

Filed Under: Food & Drug Administration (FDA), News Well, Optical/Ophthalmic, Regulatory/Compliance Tagged With: Unique Device Identifier (UDI)

FDA issues new draft guidance on Class III de novos, UDI for small entities

August 14, 2014 By Arezu Sarvestani Leave a Comment

FDA issues new draft guidance on Class III de novos, UDI for small entities

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.

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Unique Device Identifier (UDI)

Health Canada to follow IMDRF unique device identification framework

July 1, 2014 By MassDevice Leave a Comment

Health Canada to follow IMDRF unique device identification framework

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).

Filed Under: Blog, News Well, Regulatory/Compliance Tagged With: Emergo Group, Health Canada, Unique Device Identifier (UDI)

FDA finalizes unique device identifier rules

June 27, 2014 By Arezu Sarvestani Leave a Comment

FDA finalizes unique device identifier rules

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.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Unique Device Identifier (UDI)

Unique Device Identifiers: 4 tips for compliance

June 4, 2014 By Arezu Sarvestani Leave a Comment

Unique Device Identifiers: 4 tips for compliance

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.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: PricewaterhouseCoopers (PwC), Unique Device Identifier (UDI)

Going global: New AdvaMed chairman Almeida’s focus on medtech harmony around the world

April 2, 2014 By Arezu Sarvestani Leave a Comment

Harmony and ethics: New AdvaMed chairman Almeida's commitment to medtech

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.

Filed Under: News Well, Regulatory/Compliance Tagged With: AdvaMed, Covidien, Lobbying, Unique Device Identifier (UDI)

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