Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
The move comes shortly after the FDA said it was going to decline some pre-submission requests to focus on pandemic-related diagnostics.
Though it took longer than expected, the medtech industry and FDA have finally agreed on medical device user fees for the next five years.
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
On April 14, the FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.