FDA Releases Fall List of Planned Rulemakings

The FDA released its semi-annual regulatory agenda including the following proposed and final rules for medical devices and diagnostics, including:

• A final rule, expected in November, that implements a section of the FDA Safety and Innovation Act requiring the agency to use administrative orders to announce or change device classifications — instead of doing so through regulation;
• A final rule that will reclassify in vitro diagnostic devices for Bacillus detection into class II (special controls);
• A proposed rule that would establish procedures and criteria for the de novo process that increase its transparency and predictability to devicemakers. The agency did not include an expected action date for the rulemaking.