Medtech Week Recap: US FDA Increases Efficiency of Premarket Review

December 3, 2012 – 12:02 am

US FDA has shortened the average review times of premarket approvals, according to a new report by the agency. The report detailed that the agency “successfully increased the predictivity, consistency, transparency, efficiency and timeliness of premarket review.” The report is available here in pdf form: www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM329702.pdf.

Will Scanadu win the Tricoder X Prize? The company’s SCOUT device will debut at the end of 2013 and is a cloud-connected vital signs monitor. With a cost of US$150 and the ability to measure vital signs in less than 20 seconds, it has the potential to significantly advance home-health monitoring.

Eldon James announced last week that the company has received ISO 13485:2003 certification.

The Central Drugs Standard Control Organization in India released new guidelines for device regulation, marketing and licensing.

 

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