For California 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

CORA will submit PART A to California's Medicare Intermediary, Noridian. The link provided here details Noridian's required information and documentation for submission. CORA may request documents listed on the, "FDA Approved Investigational Device Exemption (IDE) Pre-Approval Data Submission Request," form (link provided below).

https://www.noridianmedicare.com/parta/forms/mr_forms/fda_approved_ide_mac.pdf

PART B

As a courtesy, CORA will submit the Investigator's Part B submission upon receipt of required documentation from Investigators. See link below for the document checklist, "FDA Approved Investigational Device Exemption (IDE) Contractor Required Information." Please identify and provide CORA with a point of contact for this process. The ultimate responsibility for Part B submission lies with the investigator.

https://www.noridianmedicare.com/partb/forms/mr_forms/fda_approved_ide_mac.pdf