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FDA Holds Off on UDI Label Enforcement for Devices Made Before September 2021

The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021.  In final guidance issued Aug. 30, the agency said stakeholders had expressed concern that pharmacies and other entities in the supply chain were not prepared [...]

By |2016-09-19T08:26:14+00:00September 19th, 2016|Government, Regulatory|0 Comments

An in-depth look at the FDA’s refurb docket

Why is this happening now? According to the docket itself, the FDA’s renewed interest in refurbishment came as a response to safety concerns brought to its attention. It’s also a chance to address ambiguities in the way certain terms associated with refurbishment and third-party service are defined. “We hope that this current effort provides additional [...]

By |2016-08-04T20:17:00+00:00August 4th, 2016|Government, Regulatory|0 Comments

The 12th Annual IAMERS European Meeting

The 12th Annual European Meeting is coming up soon on 14–16 September in Lisbon, PT. The meeting will begin on Wednesday night (14 September) with a reception and dinner. Business sessions will be held on Thursday and a partial day Friday. There will be a reception and dinner in a local restaurant on Thursday night. BUSINESS SESSIONS  Keynote [...]

By |2016-07-05T13:13:31+00:00July 5th, 2016|Event|0 Comments

Health Care Economics and Radiology

Health care is unique in its economics, but regardless of how it’s defined, an emerging market is clear: consumerism and information seeking, Saurabh Jha, MBBS, assistant professor of radiology at the Hospital of the University of Pennsylvania, said at ACR 2016. Read more here.

By |2016-06-08T10:55:07+00:00June 8th, 2016|Business|0 Comments

Who was at IAMERS and what happened?

For more than 20 years, I have been attending the IAMERS Annual Meeting. I am always glad that I attend; I always walk away a little bit smarter and it gives me the chance to see a lot of different people. This year was no exception.  Read more here. 

By |2016-05-12T16:35:52+00:00May 12th, 2016|Business|0 Comments
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