FDA Updates eSTAR Program: Human Factors Content Added and Expanded PreSTAR Functionality
The FDA has released eSTAR Version 7.0, integrating new Human Factors content and expanding PreSTAR capabilities. Learn how these changes may affect medical device manufacturers preparing FDA submissions.
FDA launches READI-Home Innovation Challenge focused on reducing hospital readmissions
The FDA launches the READI-Home Innovation Challenge to support medical devices aimed at reducing hospital readmissions through home-based care solutions.
New FDA Draft Guidance Sets Bar for Cuffless Blood Pressure Devices – Clinical Performance Now in Focus
The FDA has released a draft guidance outlining new clinical performance requirements for cuffless non-invasive blood pressure devices. Manufacturers using wearable sensors or AI must now meet specific testing standards, including ISO 81060-2. Learn how these updates affect premarket submissions and regulatory strategies.
FDA Strengthens Manufacturer Interactions Program: New Guidance on the Q-Submission Program
The FDA 's new guidance on the Q-Submission Program offers practical guidelines for manufacturers who intend to request formal feedback or technical meetings during the planning or review of regulatory submissions for medical devices and IVDs.