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 for the transition. The deadline for labeling most Class I and Class II devices is Sept. 24.

Read more here.

GE Healthcare Announces Terms of Software Non-Resale

On July 13, 2016, GE Healthcare sent a letter to IAMERS, which we understand was also sent to others who are brokers and resellers of GE Healthcare Medical Imaging Devices.  This letter details GE Healthcare’s policy on the Terms of Software Non-Resale.

Click here to read the letter.

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 clarity on how these activities are defined, and what are some key considerations on the benefits and risks associated with these activities,” Deborah Kotz, press officer of media affairs and external affairs for the FDA

Read more here.

GE asks third-parties to stop selling CT and MR with sub-licensed software on them

GE Healthcare wants brokers and re-sellers of its medical equipment to be aware that not all the software on its CT or MR systems can necessarily be bundled into the sale of the equipment itself.

Read more here.

Page 9 of 85« First...7891011...203040...Last »