New FDA Draft Guidance Sets Bar for Cuffless Blood Pressure Devices – Clinical Performance Now in Focus
The FDA has released a draft guidance outlining new clinical performance requirements for cuffless non-invasive blood pressure devices.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FDA publishes draft guidance on the transfer of 510(k) clearances: clarifications on obligations, registration and labeling
The FDA has published a new draft guidance on the transfer of 510(k) clearances, focusing on situations that do not require a new submission but do require compliance with registration, device listing and labeling update requirements. The document clarifies that the new holder must register in the FURLS/DRLM system, ensure that the 510(k) number is correctly associated with their name, and comply with UDI requirements.
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.