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," (link provided below). Please identify and provide CORA with a point of contact for this process. The ultimate responsibility for Part B submission lies with the investigator.