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4 Steps to Improve Medical Device Recall Tracking
As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
FDA finalizes recommendations simplifying approval process for medical devices that use AI
The Food and Drug Administration yesterday released recommendations for streamlining the approval process
FDA clarifies ‘remanufacturing’ in final guidance
Plus: ASHRAE publishes Standard 170 errata; cybersecurity cohort warns of OT risks; The Joint Commission launches new accreditation
FDA clarifies definition of 'remanufacturing' for medical devices needing maintenance
The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devic
Dynamic Ventilator Reserve
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The Dynamic Ventilator Reserve is a public-private partnership between the American Hospital Association, the federal government and leading group purchasing organizations. This program brings together health systems from across the country to contribute a portion of their ventilator fleets to share with hospitals experiencing shortages.
AHRMM LUC Comments to the FDA’s Communications About the Safety of Medical Devices
The AHRMM LUC members submitted public comments and recommendations at the FDA's November 2020 meeting related to the need to include the UDI in the recall process. They highlighted the prototype recall database and electronic submission form, as well as survey data supporting its creation.
I&L Committee Topic: Ethylene Oxide (EtO) Sterilization
AHRMM Issues & Legislative (I&L) Committee identifies, reviews and follows the regulatory, environmental,
AHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”
In September 2019, FDA announced its Technology Modernization Actio