FDA Classifies Endoscopic Traction Devices as Class II Medical Devices
FDA classifies the Endoscopic Traction Device as a Class II medical device with Special Controls, setting performance, safety, and labeling requirements applicable to medical device and IVD manufacturers.
New ANVISA Manual Guides Medical Device and IVD Manufacturers Through Brazil’s Regulatory Pathway
The newly published ANVISA manual provides updated guidance for the regularisation of medical devices and in vitro diagnostic products in Brazil. Covering topics such as device classification, documentation, GMP certification, and use of the Solicita system, this manual is essential for medical device and IVD manufacturers looking to expand into Brazil. By ensuring regulatory compliance, manufacturers can achieve faster access to Brazil’s large and growing healthcare market.
FDA publishes draft guidance on the transfer of 510(k) clearances: clarifications on obligations, registration and labeling
The FDA has published a new draft guidance on the transfer of 510(k) clearances, focusing on situations that do not require a new submission but do require compliance with registration, device listing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.