|CFR||Prior FDA approval/review needed||Costs recoverable that require prior FDA approval||Time limitation||Who may recover costs|
|IND-clinical study||21 CFR 312.8||Yes- amount also must be justified, documented and supported by independent CPA. FDA approval for cost recovery must be in writing||Direct costs -Ex. Raw materials, labor and nonreusable supplies and equipment used to manufacture the quantity of product used in the clinical study. Costs to obtain the product from another manufacturer. Shipping/handling costs for the product being investigated in the study.||Can charge throughout clinical study once authorized by FDA unless agency specifies time limitation.||Sponsors/ sponsor-investigators|
|IND expanded access||21 CFR 312.8||Yes as above.||Direct costs as above. Monitoring, reporting and other administrative requirements related to the expanded access IND also may be included.||One year unless shorter time specified by FDA. Can then be renewed for additional time periods.||As above|
21 CFR 812.7;
21 CFR 820(b)(8)
|No- The regulations do not require a separate prior FDA approval before cost recovery begins or a CPA statement. The proposed amount to be charged and the reason why sale does not constitute commercialization may be submitted in the original IDE application.||Manufacturing, research, development and handling||None specified except to extent sponsors may not “unduly prolong” an investigation.||812.7 applies to sponsors, investigators and/or those acting on behalf of sponsors|
Note: In some cases, as with labor/personnel costs, costs could be considered either direct or indirect depending on the specific product and how it is manufactured and distributed.