EXPANDING HUMANITARIAN USE OF DEVICES.

SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES. Section 520(m) (21 U.S.C. 360j(m)) is amended— (1) in paragraph (2), by adding after and below subparagraph (C) the following sentences: “The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.”; (2) in paragraph (4)— (A) in subparagraph (B), by inserting after “(2)(A)” the following: “, unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient”; and (B) by adding after and below subparagraph (B) the following: 111 STAT. 2335 “In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.”; (3) by amending paragraph (5) to read as follows: “(5) The Secretary may require a person granted an exemption under paragraph (2) to demonstrate continued compliance with the requirements of this subsection if the Secretary believes such demonstration to be necessary to protect the public health or if the Secretary has reason to believe that the criteria for the exemption are no longer met.”; and (4) by amending paragraph (6) to read as follows: “(6) The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 514 and 515 for a humanitarian device only after providing notice and an opportunity for an informal hearing.”.