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The FDA cited four devicemakers following inspections that revealed problems with process controls, validations, complaint handling and medical devices reports. Read More
A combination of real-world evidence and periodic reporting to the FDA should be the cornerstone of how the agency regulates AI and machine learning in software as a medical device, Philips said in a comment on the agency’s draft framework document. Read More
The shortage of notified bodies to certify devices for the new EU medical device and IVD regulations appears to be reaching crisis point as more notified bodies say they won’t be offering certification. Read More
CDER’s associate director for data analysis, Karthik Iyer, urged drugmakers to sign up for the agency’s quality metrics feedback program and the quality metrics site visit program, in a presentation at the Drug Information Association’s annual meeting in San Diego, June 23-27. Read More
Devices exempted from the tariffs include dental X-ray alignment and positioning apparatuses, multi-leaf collimators of radiotherapy systems, veterinary ultrasound devices and certain components of electrosurgical instruments. Read More