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Certain Class II device manufacturers will get two more years to comply with the FDA’s unique device identifier rule that was scheduled to become effective Sept. 24. Read More
Data from patients will add to the body of evidence used to assess devices, both in the approval process and for postmarket safety, FDA Commissioner Robert Califf told devicemakers. Read More
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. Read More
The FDA plans to unveil by Oct. 1 its own quality metrics for devicemakers based on three metrics from a pilot program conducted by Xavier Health and the Medical Device Innovation Consortium. Read More
The FDA found process validation, medical device reporting and other quality system failures at Biotronik’s Berlin facility during a recent inspection. Read More
Japan’s Mitaka Kohki failed to establish design control procedures, CAPA procedures, equipment calibration procedures, and documentation was found lacking for numerous critical processes during an inspection of the Tokyo-based facility. Read More
TriMed, a maker of implantable bone fixation systems, failed to report a device failure that required surgery to remove the device, according to an FDA warning letter. Read More
The UK’s Medicines and Healthcare products Regulatory Agency issued safety warnings on two pediatric products manufactured by Germany’s Dragerwerk AG & Co. Read More
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