Sec. 206. REAUTHORIZATION OF REVIEW
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## SEC. 206 REAUTHORIZATION OF REVIEW Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m) is amended— ####
(1)in subsection (a)(3)— #####
(A)in subparagraph (A), by striking clauses
(ii)and
(iii)and inserting the following: > > ###### “(ii) > > a device classified under section 513(f)(2) or designated under section 515C(d); > > > ###### “(iii) > > a device that is intended to be permanently implantable, life sustaining, or life supporting, unless otherwise determined by the Secretary in accordance with subparagraph (B)(i)(II) and listed as eligible for review under subparagraph (B)(iii); or > > > ###### “(iv) > > a device that is of a type, or subset of a type, listed as not eligible for review under subparagraph (B)(iii).” > ; #####
(B)by striking subparagraph
(B)and inserting the following: > > ##### “(B) Designation for review > > The Secretary shall— > > > ###### “(i) > > issue draft guidance on the factors the Secretary will use in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person, including— > > > ###### “(I) > > the risk of the device type, or subset of such device type; and > > > ###### “(II) > > whether the device type, or subset of such device type, is permanently implantable, life sustaining, or life supporting, and whether there is a detailed public health justification for permitting the review by an accredited person of such device type or subset; > > > ###### “(ii) > > not later than 24 months after the date on which the Secretary issues such draft guidance, finalize such guidance; and > > > ###### “(iii) > > beginning on the date such guidance is finalized, designate and post on the internet website of the Food and Drug Administration, an updated list of class I and class II device types, or subsets of such device types, and the Secretary’s determination with respect to whether each such device type, or subset of a device type, is eligible or not eligible for review by an accredited person under this section based on the factors described in clause (i).” > ; and #####
(C)by adding at the end the following: > > ##### “(C) Interim rule > > Until the date on which the updated list is designated and posted in accordance with subparagraph (B)(iii), the list in effect on the date of enactment the Medical Device User Fee Amendments of 2017 shall be in effect.” > ; ####
(2)in subsection (b)— #####
(A)in paragraph (2)— ######
(i)by striking subparagraph (D); and ######
(ii)by redesignating subparagraph
(E)as subparagraph (D); and #####
(B)in paragraph (3)— ######
(i)by redesignating subparagraph
(E)as subparagraph (F); ######
(ii)in subparagraph
(F)(as so redesignated), by striking “The operations of” and all that follows through “it will—” and inserting “Such person shall agree, at a minimum, to include in its request for accreditation a commitment to, at the time of accreditation, and at any time it is performing any review pursuant to this section—”; and ######
(iii)by inserting after subparagraph
(D)the following new subparagraph: > > ##### “(E) > > The operations of such person shall be in accordance with generally accepted professional and ethical business practices.” > ; and ####
(3)in subsection (c), by striking “2017” and inserting “2022”.
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Sec. 206
REAUTHORIZATION OF REVIEW
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