Last Friday, the Biden administration rejected a plan proposed in the last days of the Trump administration that aimed to stop the reviews of many medical products and AI medical software.
Indeed, it was stated by the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) that the proposal was riddled with errors and ambiguities as well as didn’t have any scientific support. The proposal sought to make permanent some changes that were introduced last April, which would provide regulatory relief to medical companies during the pandemic.
At the time, however, the FDA had relaxed its regulatory requirements in order to respond more quickly to the outbreak, and thus, proposed to remove the necessary reviews for medical products, including AI and computer-aided detection (CAD) software.
Hence, the proposal said that review requirements under the 510(k) pathway could be lifted for products ranging from CT lung CAD software to acoustic holography devices.
However, this move proved itself very dangerous as it could lead to the use of unregulated and unsafe AI in the medical environment. Many radiology groups including the RSNA, the American College of Radiology, and the Society for Imaging Informatics in Medicine went against it.
Following this, the HHS and FDA decided to review the proposal ad found several errors and ambiguities. Thus, the proposal was deemed inadequate and flawed and was rejected.