costs of resources allocated for the process for the review of device applications

(10) The term “costs of resources allocated for the process for the review of device applications” means the expenses in connection with the process for the review of device applications for— (A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors; (B) management of information, and the acquisition, maintenance, and repair of computer resources; (C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and (D) collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, submissions, and de novo classification requests.

Source

21 USC § 379i(10)


Scoping language

For purposes of this subpart
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