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 has established a new Class II classification with special controls for transcutaneous electrical nerve stimulators (TENS) intended to treat fibromyalgia symptoms, creating a new regulatory pathway for manufacturers.

The FDA has published its final guidance on Human Factors information in medical device submissions, introducing a new risk-based framework and three Human Factors Submission Categories. Learn what manufacturers need to know.

FDA Recognition List 065 updates biocompatibility standards, including ISO 10993-4 Amendment 1 and multiple ASTM revisions. Impact for manufacturers.

The FDA has released a draft guidance outlining new clinical performance requirements for cuffless non-invasive blood pressure devices.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.

The FDA has published a new draft guidance on the transfer of 510(k) clearances, focusing on situations that do not require a new submission but do require compliance with registration, device listing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.

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.