FDA Announces Initiative To Reclassify High-Risk IVDs To Make Them Eligible for 510(k) Clearance
February 7, 2024 at 02:46 PM EST
The FDA has announced its intention to reclassify most in vitro diagnostics (IVDs) currently in Class III (high risk) as Class II (moderate risk) devices, allowing manufacturers to seek marketing authorization through the less burdensome premarket notification (510(k)) pathway rather than the more stringent premarket approval (PMA) process.
The announcement from the Center fo... Read More
