The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget for review under the Paperwork Reduction Act. This collection involves the De Novo classification process, which evaluates if a medical device can be classified as class I or II, assuring its safety and effectiveness in the absence of a similar marketed device. The process includes regulatory guidelines and electronic submission templates. Feedback on the proposal is welcomed until January 29, 2025, via the OMB's online portal.
Simple Explanation
The FDA is asking for feedback on a new way to decide if a medical gadget is safe for people to use. They're making it easier with online forms, and everyone has until January 29, 2025, to say what they think.