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“We wish to send a clear signal to the world that the Danish Medicines Agency is disconnected from economic interests of pharmaceutical and medical device companies,” the agency’s director general said. Read More
After months of criticism of the European Commission for the slow release of guidance on the EU’s new medical device regulations, the Commission released a flurry of documents on the Eudamed data exchange. Read More
Covington & Burling attorney Pamela Forrest offered insights into when devicemakers must file recall reports with the FDA to comply with 21 CFR Part 806 in a recent FDAnews webinar, flagging areas of confusion and how to avoid common errors. 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
The agency notes that the main purpose of an IFU is to provide “detailed, action-oriented, step-by-step written and visual instructions in a patient-friendly manner.” Read More
The FDA issued a final rule on appealing CDRH’s significant decisions about medical devices, including procedures for submitting requests and timelines for the agency’s responses. Read More