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The number of Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) applications and certificates in the European Union (EU) increased significantly in a recent six-month period, signaling some success in addressing the need for recertification to meet the EU’s new regulations. Read More
Risk management plans need to be continually updated as the design of a medical device or in vitro diagnostic evolves, said quality expert Dave Petrich in a July 19 webinar from FDAnews, a WCG company. Read More
Baxter Healthcare’s recall of 23,000 infusion pumps due to repeat upstream occlusion false alarms has been deemed class I by the FDA, the most serious type of recall as use of the device may cause injury or death. Read More
In the third revision to its guideline on good clinical practice, ICH E6, the International Council on Harmonisation (ICH) is proposing a full-scale restructuring of the document that has provided a global standard for sponsors, sites and investigators since 1996. In this blog post from Avoca, a WCG company, Karen Harvey, senior director of the Avoca Quality Consortium, outlines the changes in the new ICH draft guideline.Read More
This week, three medical devices used for cardiac issues were deemed class I by the FDA, the most serious type of recall, as use of the device may cause serious injury or death. Read More
HHS announced plans to issue several FDA-related proposed and final rules in the coming year in its semiannual inventory of rulemaking actions. Read More
While prescription drug user fees increased a hefty 19.9 percent and medical device fees a modest 8.7, fees for biosimilar applications dropped up to an eye-popping 373 percent. Read More
Recommendations for study design to facilitate innovation in development of devices, such as deep brain, transcranial magnetic and spinal cord stimulations, intended to treat opioid use disorder (OUD) are the subject of a draft guidance issued July 27. Read More
More than 20 billion devices are sterilized with EtO each year, CDRH says, representing about 50 percent of devices that require sterilization. Read More