FDA Adds New Clinical Outcome Assessment Case Studies for Devices
The FDA’s Center for Devices and Radiological Health (CDRH) has posted a number of new clinical outcome assessment (COA) case studies for medical device trials.
The case studies describe COAs approved by CDRH under its Medical Device Development Tools (MDDT) program. CDRH recommends sponsors, institutions and investigators developing their own COA tools review the case studies as illustrations of the kind of tools MDDT will approve.
Read the COA case studies here: https://bit.ly/3qiroek.