Expect Future FDA Clarification on Machine Learning-Enabled Medical Devices
The inaugural AAMI/FDA neXus medical device standards conference was held February 20-23, 2024 in Washington DC. The conference was hosted by the Association for the Advancement of Medical Instrumentation (AAMI)....
FDA Issues Warning about Fraudulent and Unreliable Laboratory Data
The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable...
Updates in the FDA’s Regulation of Digital Health Technologies
The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software...
Shutdown will Impact FDA
The looming government shutdown will likely slow the pace of work at the FDA. The federal government will shut down on October 1, 2023 unless a deal is reached. In the event...