Search Results for keywords:"device safety"

The Food and Drug Administration (FDA) has sent a proposed information collection to the Office of Management and Budget (OMB) as part of the Paperwork Reduction Act of 1995. This proposal concerns the process of submitting petitions to reclassify medical devices, which involves determining the level of regulatory control necessary for a device to be safe and effective. The FDA has outlined specific rules and formats for these reclassification petitions. The proposal, which shows an increase in submissions and associated workload, is open for public comments until January 17, 2025.

The Food and Drug Administration (FDA) has released a final guidance document on marketing submissions for devices with artificial intelligence-enabled software. This guidance provides recommendations for including a Predetermined Change Control Plan (PCCP) in submissions, which outlines planned AI software modifications, their development and validation, and their potential impact. The FDA aims to streamline the approval process for such modifications by avoiding repeated marketing submissions while ensuring device safety and effectiveness. The guidance reflects the FDA's efforts to regulate AI-enabled medical device software innovatively and effectively.