Page:United States Statutes at Large Volume 111 Part 3.djvu/251

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PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2339 (1) in subsection (k), in the matter preceding paragraph (1), by adding after "report to the Secretary" the following: "or person who is accredited under section 523(a)"; and (2) by adding at the end the following subsections: "(1) A report under subsection (k) is not required for a device intended for human use that is exempted from the requirements of this subsection under subsection (m) or is within a type that has been classified into class I under section 513. The exception established in the preceding sentence does not apply to any class I device that is intended for a use which is of substantial importance in preventing impairment of human health, or to any class I device that presents a potential unreasonable risk of illness or injury. "(m)(l) Not later than 60 days after the date of enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall publish in the Federal Register a list of each type of class II device that does not require a report under subsection (k) to provide reasonable assurance of safety and effectiveness. Each t3rpe of class II device identified by the Secretary as not requiring the report shall be exempt from the requirement to provide a report under subsection (k) as of the date of the publication of the list in the Federal Register. "(2) Beginning on the date that is 1 day after the date of the publication of a list under this subsection, the Secretary may exempt a class II device from the requirement to submit a report under subsection (k), upon the Secretary's own initiative or a petition of an interested person, if the Secretary determines that such report is not necessary to assure the safety and effectiveness of the device. The Secretary shall publish in the Federal Register notice of the intent of the Secretary to exempt the device, or of the petition, and provide a 30-day period for public comment. Within 120 days after the issuance of the notice in the Federal Register, the Secretary shall publish an order in the Federal Register that sets forth the final determination of the Secretary regarding the exemption of the device that was the subject of the notice. If the Secretary fails to respond to a petition within 180 days of receiving it, the petition shall be deemed to be granted.". (b) SECTION 513(f).— Section 513(f) (21 U.S.C. 360c(f)) is amended by adding at the end the following: "(5) The Secretary may not withhold a determination of the initial classification of a device under paragraph (1) because of a failure to comply with any provision of this Act unrelated to a substantial equivalence decision, including a finding that the facility in which the device is manufactured is not in compliance with good manufacturing requirements as set forth in regulations of the Secretary under section 520(f) (other than a finding that there is a substantial likelihood that the failure to comply with such regulations will potentially present a serious risk to human health).". (c) SECTION 513(i). —Section 513(i)(l) (21 U.S.C. 360c(i)), as amended by section 205(b), is amended— (1) in subparagraph (A)(ii)— (A) in subclause (I), by striking "clinical data" and inserting "appropriate clinical or scientific data" and by inserting "or a person accredited under section 523" after "Secretary"; and (B) in subclause (II), by striking "efficacy" and inserting "effectiveness"; and Federal Register, publication. Federal Register, publication. Federal Register, publication.