HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process.
In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided to immediately stop reviewing for 510(k) clearance.
Get the full story on our sister site, Medical Design & Outsourcing.