CDRH Proposes Network to Help Inform Device Decisionmaking

To better understand device performance and risks, CDRH hopes to create a network of academic institutes with epidemiologic and statistical expertise by the end of June. As envisioned by CDRH, the Medical Device Epidemiology Network will establish a research infrastructure to link information from various device registries and databases to determine evidence gaps, questions, datasets and approaches for conducting analytic studies. The network also will be expected to conduct comparative-effectiveness studies.
Devices & Diagnostics Letter