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The narrative that LDTs are intangible services whereas medical devices are tangible objects has been a core argument from the laboratory industry for decades as they have battled the US Food and Drug Administration (FDA) on their claimed regulatory authority over the tests. FDA has argued that LDTs are indeed tangible objects – the physical instruments that are analyzing the physical patient specimen and providing a test result. Well, the war of definitions has come to an en

FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations are listed on a Form FDA 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s regulations.

On July 31, 2024, the U.S. Food and Drug Administration (FDA) posted a Federal Register notice announcing the Medical Device User Fee Rates for Fiscal Year 2025. The fees have increased by 11.8%, with the exception of the establishment registration fee, which increased by 21.3%.

On May 21, 2024, the United Kingdom’s (UK) Medicine and Healthcare Products Regulatory Agency (MHRA) announced their draft policy for recognizing international regulators’ approvals of medical devices. This stems from their response to the 2021 consultation on the future regulation of medical devices in the United Kingdom, which detailed the intention to introduce alternative routes to market into Great Britain.