30 gations of the device (including, where appropriate, tests on animals) adequate to justify the proposed test ing, either (i) to a local institutional review committee for review and approval in accordance with the pro visions of clauses (A) (i) and (B), or (ii) to the Secretary for review and approval in accordance with the provisions of clause (A) (ii) if such testing involves facilities in which no such committee exists, or facilities served by more than one local institutional review committee if such committees are unable to agree on the adequacy of the submission; "(D) the obtaining, by the manufacturer, of the device or the sponsor of the investigation, if the device is to be distributed to investigators for testing, of a signed agreement from each of such investigators that humans upon whom the device is to be used will be under such investigator's personal supervision or under the supervision of investigators responsible to him; "(E) the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer of the device or the sponsor of the investigation, of data (including but not limited to analytical reports by investigators) obtained as a result of such investigational use of the device, as the Secretary finds will enable him to evaluate the safety and effective 31 1 2 3 4 5 ness of the device in the event of the filing of an appli cation pursuant to subsection (c); and "(F) such other conditions relating to the protec tion of the public health and safety as the Secretary may determine to be necessary. 6 Nothing in this subsection shall be construed to require any 7 clinical investigator to submit directly to the Secretary reports 8 on the investigational use of devices. 9 "(5) Such regulations shall condition such exemption 10 upon the manufacturer of the device, or the sponsor of the 11 investigation, requiring that investigators using the device 12 certify to such manufacturer or sponsor that they 13 14 15 16 17 18 "(A) will inform individuals upon whom such device or any controls in connection therewith are used, or the representatives of such individuals, that the device is being used for investigational purposes, and "(B) will obtain the consent of such individuals or representatives, 19 except where such investigators deem it not feasible or, in 20 their professional judgment, contrary to the best interest of 21 such individuals. 22 "(6) Whenever the Secretary determines that a device 23 is being or has been shipped or delivered for shipment in 24 interstate commerce for investigational testing upon humans, 25 and that such device is subject to the preceding subsections 32 1 of this section and fails to meet the conditions for exemption 2 therefrom for investigational use, he shall notify the sponsor 3 of his determination and the reasons therefor, and the exemp4 tion will not thereafter apply with respect to such investiga5 tional use until such failure is corrected. 6 “(7) In determining whether this subsection is appli7 cable to any device and, if so, whether there has been 8 compliance with the conditions of exemption, or upon appli9 cation for reconsideration of any such determination, the 10 Secretary shall, if so requested by the sponsor of the investiga11 tion, or may on his own initiative, obtain the advice of an 12 appropriate expert or experts who are not otherwise, except as consultants, engaged in the carrying out of this Act. 13 14 66 "(1) (1) If, on the day immediately prior to the date 15 upon which a device is declared to be subject to scientific 16 review under this section, the device was in use in the di17 agnosis, cure, mitigation, treatment, or prevention of disease in man, or for the purpose of affecting the structure or any 18 19 function of the body of man, section 501 (f) shall become ef20 fective with respect to such preexisting use or uses of such 21 device on the closing date (as defined in paragraph (2) of 22 this subsection) or, if sooner, on the effective date of an 23 order of the Secretary approving or denying approval of an 24 application with respect to such use of the device under this 25 section. 33 1 "(2) For the purposes of this subsection, the term 'clos2 ing date' means, with respect to a device, the first day of 3 the thirty-first calendar month which begins after the month 4 in which the device is declared to be subject to scientific 5 review under this section, except that, if in the opinion of 6 the Secretary it would not involve any undue risk to the 7 public health, he may on application or on his own initiative 8 postpone such closing date with respect to any particular 9 use or uses of a device until such later date (but not beyond 10 the close of the sixtieth month after the month of such 11 declaration) as he determines is necessary to permit com12 pletion, in good faith and as soon as reasonably practicable, 13 of the scientific investigations necessary to establish the safe14 ty and effectiveness of such use or uses. The Secretary may 15 terminate any such postponement at any time if he finds that 16 such postponement should not have been granted or that, by 17 reason of a change in circumstances, the basis for such post18 ponement no longer exists or that there has been a failure 19 to comply with a requirement of the Secretary for submission 20 of progress reports or with other conditions attached by him to such postponement." 21 22 23 PROHIBITED ACTS SEC. 202. (a) Paragraph (e) of section 301 of such 24 Act is amended (1) by striking out "or" before “512 (j), 34 1 (1), or (m)"; and (2) by inserting “, 514 (k), or 516 (a)” 2 after "512 (j), (1), or (m)". 3 (b) Paragraph (j) of section 301 of such Act is amend4 ed by inserting "514, 516," immediately after "512,". 5 (c) Paragraph (1) of such section 301 is amended 6 (1) by inserting "or device" after the word "drug" each 7 time it appears therein, and (2) by striking out "505," and 8 inserting in lieu thereof "505 or 514, as the case may be,". TITLE III-NOTIFICATION OF DEFECTIVE 9 10 11 DEVICES; REPAIR OR REPLACEMENT SEC. 301. Chapter V of such Act, as amended by sec12 tions 101 and 201 (b) of this A t, is further amended by 13 adding at the end thereof the following new section: 14 15 16 "NOTIFICATION OF DEFECTS IN, AND REPAIR OR REPLACEMENT OF, DEVICES "SEC. 515. (a) (1) Every person who acquires infor 17 mation which may reasonably be understood to show that 18 a device produced, assembled, or imported by him (A) 19 contains a defect which is likely to create a substantial risk 20 to the health or safety of any person, or (B) on or after 21 the effective date of an applicable standard promulgated 22 pursuant to section 513 fails to comply with such standard, 23 shall immediately notify the Secretary of such defect or 24 failure to comply if such device has left the place of manu25 facture and shall, except as otherwise provided by paragraph |