For Texas Providers:
Please note: the information provided here refers to Category B IDEs, which
makes up the majority of IDEs. If the study IDE falls into the Category
A IDE, please contact CORA.
PART A & B
As a courtesy, CORA will submit the full Part A
and Part B Cover Letter to Texas' Medicare Intermediary Novitas Solutions.
The link provided here details Novitas' required information and documentation
for submission. CORA may request documents listed on the, "FDA-Approved
Clinical Trial/Device Request Submission Checklist."
View the requirements.
Please identify and provide CORA with a point of contact for this process.
The ultimate responsibility for Part B submission lies with the investigator.