The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection related to medical device shortages. Under the Paperwork Reduction Act, they must announce proposed data collection plans and allow a 60-day public comment period. This data will help the FDA manage medical device availability during emergencies by obtaining information on production changes that could cause shortages. Additionally, the CARES Act gives FDA the power to require notifications from manufacturers about disruptions that could impact device supply, especially during public health emergencies.
Simple Explanation
The FDA is asking people to share their thoughts about a plan to collect information from companies that make medical devices. This will help the FDA know if there could be problems with making these devices, especially during emergencies like a big health crisis.