Regulatory

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.

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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

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FDA announces public workshop to discuss third-party refurb docket

Now that the commenting period has ended, the FDA plans to host a two-day public workshop for stakeholders to discuss the questions raised in its third-party service and refurbished medical device docket.

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OMB receives CMS rules overhauling Medicaid

The CMS has sent a sweeping finalized rule that will overhaul the managedMedicaid program to the Office of Management and Budget for review. The 653-page proposed version of the rule suggested the biggest changes in Medicaid managed-care regulations in more than a decade. It would cap insurer profits, require states to more rigorously supervise the adequacy of plans’ provider networks, encourage states to establish quality rating systems for plans, allow more behavioral healthcare in institutional settings and encourage the growth of managed long-term care.  
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