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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.
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.
AHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”
In September 2019, FDA announced its Technology Modernization Actio
I&L Committee Topic: Ethylene Oxide (EtO) Sterilization
AHRMM Issues & Legislative (I&L) Committee identifies, reviews and follows the regulatory, environmental,