FDA publishes labeling recommendations for hernia mesh: focus on safety and proper device selection
The new FDA guidance proposes improvements in the labeling of surgical hernia mesh, with the aim of reducing adverse events and facilitating device selection by healthcare professionals. Among the recommended data are mesh composition, physical characteristics and mechanical properties. The initiative applies to devices specifically indicated for hernia repair and encourages manufacturers to update the labeling in their submissions to the FDA.
FDA publishes draft guidance on the transfer of 510(k) clearances: clarifications on obligations, registration and labeling
The FDA has published a new draft guidance on the transfer of 510(k) clearances, focusing on situations that do not require a new submission but do require compliance with registration, device listing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.