Waiver for Additional Investigational Sites

(Excerpt from the IDE Form Letter To A Sponsor)

FDA will waive those requirements regarding submission and prior FDA approval of a supplemental application and receipt of certification of institutional review board (IRB) approval for the addition of investigational sites [21 CFR 812.35(b)] provided:

• The total number of investigational sites does not exceed [##] (number is provided by the submitter).
• You maintain current records on:
  • the names and addresses of all investigational sites
  • the names and addresses of all investigators, identifying those who are currently participating
  • the names, addresses and chairpersons of all IRBs
  • the dates of IRB approvals
  • the dates of first shipment or first use of investigational devices for all participating institutions.
• Within 5 days of reaching the investigational site limit, you submit to FDA a current list containing the information specified in 2(a­e) above.
• The current investigator list to be submitted to FDA at 6-month intervals [21 CFR 812.150(b)(4)] will contain the information specified in 2(a­e) above.
• You submit to FDA, within 2 days of receipt of a request by FDA, a current list containing the information specified in 2(a­e) above.
• The reviewing IRB does not require any significant changes in the investigational plan or in the informed consent, that is, require any change which may increase the risks to subjects or affect the scientific soundness of the study. (Please note: If a significant change is requested, this change must be submitted to FDA for review and approval prior to initiating the study at that investigational site.) Minor changes requested by the IRB may be made without prior FDA approval.

If you agree to these conditions, you may begin an investigation at a new investigational site after the IRB has approved the investigation. No documentation should be submitted for any institution within the approved limit until the investigational site limit is reached or the 6­month current investigator list is due. FDA assumes that you have agreed to the conditions of this waiver unless you specifically notify us in writing of your disagreement. Please note, however, that you must submit a supplemental IDE application, and receive FDA approval, prior to expanding the investigation beyond the limit specified above. Additionally, if you do not agree to these conditions, you must comply with the full requirements for the submission to FDA of a supplemental IDE application for new investigational sites not already specifically approved for participation in your study (21 CFR 812.35(b)).