Page:United States Statutes at Large Volume 111 Part 3.djvu/254

 Ill STAT. 2342 PUBLIC LAW 105-115—NOV. 21, 1997 SEC. 210. ACCREDITATION OF PERSONS FOR REVIEW OF PREMARKET NOTIFICATION REPORTS. (a) IN GENERAL. — Subchapter A of chapter V is amended by adding at the end the following: 21 USC 360m. "SEC. 523. ACCREDITED PERSONS. "(a) IN GENERAL.— "(1) REVIEW AND CLASSIFICATION OF DEVICES.—Not later than 1 year after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall, subject to paragraph (3), accredit persons for the purpose of reviewing reports submitted under section 510(k) and making recommendations to the Secretary regarding the initial classification of devices under section 513(f)(1). "(2) REQUIREMENTS REGARDING REVIEW.— "(A) IN GENERAL.—In making a recommendation to the Secretary under paragraph (1), an accredited person shall notify the Secretary in writing of the reasons for the recommendation. "(B) TIME PERIOD FOR REVIEW.— Not later than 30 days after the date on which the Secretary is notified under subparagraph (A) by an accredited person with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification. "(C) SPECIAL RULE.—The Secretary may change the initial classification under section 513(f)(1) that is recommended under paragraph (1) by an accredited person, and in such case shall provide to such person, and the person who submitted the report under section 510(k) for the device, a statement explaining in detail the reasons for the change. "(3) CERTAIN DEVICES. — "(A) IN GENERAL.—An accredited person may not be used to perform a review of— "(i) a class III device; "(ii) a class II device which is intended to be permanently implantable or life sustaining or life supporting; or "(iii) a class II device which requires clinical data in the report submitted under section 510(k) for the device, except that the number of class II devices to which the Secretary applies this clause for a year, less the number of such reports to which clauses (i) and (ii) apply, may not exceed 6 percent of the number that is equal to the total number of reports submitted to the Secretary under such section for such year less the number of such reports to which such clauses apply for such year. "(B) ADJUSTMENT.—In determining for a year the ratio described in subparagraph (A)(iii), the Secretary shall not include in the numerator class III devices that the Secretary reclassified into class II, and the Secretary shall include in the denominator class II devices for which reports under section 510(k) were not required to be submitted by reason of the operation of section 510(m). "(b) ACCREDITATION. —

�