FDA announces consolidation of regulatory oversight responsibilities for fat transfer devices that process adipose tissue for return to the body
The proper surveillance of medical devices is necessary to ensure the health and safety of the public, and the Food and Drug Administration is committed to accuracy in oversight. The FDA has recently announced a consolidation of regulatory oversight responsibilities for fat transfer devices that process adipose tissue for return to the body within the Center for Biologics Evaluation and Research (CBER).
Two centers within the FDA regulate medical devices: CBER and the Center for Devices and Radiological Health (CDRH). CDRH provides the public with regulatory oversight and accessible science-based information on medical devices and non-medical radiation-emitting products. CBER ensures that biological products like human cells, tissues, and cellular and tissue-based products (HCT/Ps) are safe and effective and promotes the appropriate use of biological products to the public.
Devices that process autologous HCT/Ps at the point of care will be affected by this new regulation, specifically fat transfer devices — that is, devices that process adipose tissue for return to the body — currently under the product code MUU. These devices are currently regulated by CDRH. However, because the output is intended to provide a therapeutic benefit, these devices will now be assigned to CBER. This action aims to ensure that all HCT/P devices are regulated by the same FDA center.
This announcement is welcome news for GID BIO and other research companies that are dedicated to the safety of their patients and determined to drive innovation through research-based outcomes.
Read more about the FDA’s decision here.