The FDA recently announced its planned enhancements to the Electronic Medical Device Reporting (eMDR) System. The purpose of the announcement was to...
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Earlier this year, the FDA’s Center for Devices and Radiological Health (“CDRH”) published a new public dataset to assist chemistry laboratories in...
Following years of discussion and debate, the FDA officially published its final rule covering laboratory developed tests (“LDTs”) on May 6, 2024....
On April 25, 2024, the European Commission issued a press release announcing that additional time will be granted to companies to transition to the...
Cybersecurity continues to evolve throughout all facets of the business world, and the medical device industry has taken notice. FDA has published...
On March 13, 2024, the European Parliament approved the Artificial Intelligence Act (“AIA”), which represents the first comprehensive legal framework...
On January 31, 2024, the FDA issued its highly-anticipated Quality Management System Regulation (“QMSR”) Final Rule which amends current good...
