The Department of Health and Human Services and the Food and Drug Administration (FDA) are proposing to permanently waive certain premarket notification requirements for specific medical devices. This action follows temporary waivers provided during the COVID-19 pandemic to make medical devices more accessible. The proposal includes making seven class I devices and 84 class II devices permanently exempt from the 510(k) premarket notification requirement, which typically involves a costly and time-consuming process. The public is invited to comment on the proposed exemptions and suggest improvements to the regulatory system concerning medical devices.
Simple Explanation
The FDA says they want to make it easier and faster for certain medical gadgets to be available by skipping a long check-up process they usually do. They want to hear what people think about this idea and how they could make the process even better.