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March 25, 2019

UPDATE to IDE (Investigational Device Exemption) Submission Process

INITIAL SUBMISSIONS:
To help streamline our processes for IDE submissions that have been approved by CMS effective immediately CGS will now only require the following:

  1. CMS approval letter
  2. IRB approval letter

Along with the above 2 requirements please include a letter with the following information:

  1. PTAN of the facility,
  2. Name(s) of the principal investigator with NPI
  3. Names of the sub-investigators with NPI numbers

The above information is necessary to input into the Medicare claims payment systems to assure proper processing of claims related to such trial.

CHANGES ONLY (i.e. extensions, protocol changes, reportable Adverse Events):
To help streamline our processes for IDE submissions that are changes ONLY effective immediately CGS will now only require the following:

  1. IRB Approval Letter
  2. Letter that includes the following:
  3. Any changes to the facility or investigators
    1. Please be sure to include ADD or DELETE with these changes
  4. Any Protocol Changes
    1. Please be sure to include a brief summary of the changes
  5. Current (since last submission) list of IRB reportable Adverse Events

TO AVOID DELAYS IN PROCESSING YOUR REQUEST BE SURE TO INCLUDE ALL REQUIRED INFORMATION AS LISTED ABOVE.

For further information on Clinical Trials:

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