The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget (OMB) for review, as required under the Paperwork Reduction Act of 1995. This proposal relates to tracking certain high-risk medical devices, which helps to quickly locate devices and notify patients or practitioners about recalls or risks. The collection applies to manufacturers, importers, and distributors of these medical devices, and aims to ensure effective tracking and information sharing in case of device defects. The FDA has estimated that the annual burden for respondents is around 615,380 hours, with approximately 22,000 entities subject to these tracking requirements.
Simple Explanation
The FDA wants to keep track of some medical machines to make sure they are safe and can be found quickly if needed. This involves asking companies to share information, and it's a really big job that takes a lot of time.