November 01, 2023
The Food and Drug Administration is seeking nominations for nonvoting industry representatives to serve on specific panels of the Medical Devices Advisory Committee (MDAC) within the Center for Devices and Radiological Health (CDRH). This call for nominations aims to enhance the inclusion of industry knowledge in the evaluation and regulation of medical devices.
The MDAC helps review and assess the safety and effectiveness of both marketed and investigational medical devices. It provides recommendations on device classification, potential health risks associated with device use, product development protocols, premarket approval applications, guidelines and exemption of certain devices from specific regulations. The committee also addresses issues related to clinical studies' design and categorization of in vitro diagnostics under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
Of particular significance to the blood and biotherapies community, FDA's call for nominations includes the opportunity to serve on the MDAC's Hematology and Pathology Devices Panel. This panel focuses on evaluating in vitro devices used in clinical laboratory medicine, encompassing fields such as pathology, hematology, histopathology, cytotechnology and molecular biology.
Individuals interested in contributing as nonvoting industry representatives on the committee may self-nominate or be nominated by an organization. Detailed instructions are available in the Federal Register notice. FDA also encourages industry organizations interested in participating in the selection process for nonvoting industry representatives to express their interest by Dec. 1.
AABB strongly encourages its members involved in the creation of laboratory-developed tests (LDTs) to consider applying to serve on the committee, as LDTs would be considered as medical devices under FDA’s proposed LDT rule. Furthermore, AABB reminds community members that the agency is accepting feedback on the proposed LDT rule though Dec. 4.