“Saying the proposal was riddled with “errors” and “ambiguities,” the Biden administration on April 16 torpedoed a plan proposed in the waning days of the Trump administration to eliminate 510(k) reviews for a range of medical products, including artificial intelligence (AI) software.”
“In a statement, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) said the proposal issued January 15 by the Trump administration to make some devices and software exempt from regulatory review was “published without adequate scientific support,” and the notice itself was flawed.”
“The January 15 notice proposed to make permanent a number of regulatory changes introduced in April 2020 that were designed to provide regulatory relief to medical companies during the COVID-19 public health emergency. The FDA at that time had relaxed a number of its regulatory requirements in an effort to help clinicians and vendors respond more quickly to the pandemic.”
“For example, the FDA temporarily lifted the need for additional review of modifications made to medical imaging devices that had already received 510(k) clearance, such as a portable x-ray machine that might be modified to operate behind glass to reduce infection risk to medical personnel.”
“But the January 15 proposal went even further, proposing to eliminate review requirements for broad classes of products, in particular artificial intelligence and computer-aided detection (CAD) software. Review requirements under the 510(k) pathway would be lifted for products ranging from CT lung CAD software to acoustic holography devices; even fluoroscopy systems and MRI coils would be exempted.”
“But many industry observers immediately questioned the wisdom of the proposal, with one Twitter user calling it “extremely dangerous and short-sighted,” and saying it would lead to the use of “unregulated AI” in the clinical environment. The proposal also drew letters of opposition from radiology groups such as the RSNA, the American College of Radiology, and the Society for Imaging Informatics in Medicine…” Read the full article here.
Source: Biden administration nixes FDA plan to lift reviews of AI software — By Brian Casey, April 16, 2021. AuntMinnie.com.