Friday In-Focus State of the Art – From Claims to Strategy

The session reviewed what the presenters see happening at FDA in 2025, starting with the administration’s regulatory freeze, the 10-to-1 deregulation order, and reductions in force. They described how those actions are affecting medical devices by looking first at food and drugs, then predicting similar deregulation pressure on CDRH. They explained that de novos are still being granted, but new regulation numbers can be placeholders, so companies may be unable to use recent de novos as predicates because special controls and decision summaries are not fully available. They also discussed the public comment process for removing regulations and guidance, the practical difficulty of submitting comments, and examples of FDA using outdated guidance alongside newer standards. The conversation covered staffing turmoil and the October 1 government shutdown, which stopped FDA from accepting new submissions or fees, including FY26 registration fees. They reviewed foreign inspection plans and the paused unannounced-inspection pilot, then turned to guidance updates, 510(k) and pre-submission review times, and FDA’s use of AI tools such as ELSA and PREDICT. They closed with Q&A, including uncertainty about Q-Submissions during the shutdown and the need to verify AI-generated feedback.