Sec. 617. CUSTOM DEVICES
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## SEC. 617 CUSTOM DEVICES Section 520(b) (21 U.S.C. 360j(b)) is amended to read as follows: > > ### “(b) Custom Devices > > > #### “(1) In general > > The requirements of sections 514 and 515 shall not apply to a device that— > > > ##### “(A) > > is created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing); > > > ##### “(B) > > in order to comply with an order described in subparagraph (A), necessarily deviates from an otherwise applicable performance standard under section 514 or requirement under section 515; > > > ##### “(C) > > is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution; > > > ##### “(D) > > is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat; > > > ##### “(E) > > > ######
(i)> > is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated); or > > > ###### “(ii) > > is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated); > > > ##### “(F) > > is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals described in clause
(i)or
(ii)of subparagraph (E); and > > > ##### “(G) > > may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices. > > > #### “(2) Limitations > > Paragraph
(1)shall apply to a device only if— > > > ##### “(A) > > such device is for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical; > > > ##### “(B) > > production of such device under paragraph
(1)is limited to no more than 5 units per year of a particular device type, provided that such replication otherwise complies with this section; and > > > ##### “(C) > > the manufacturer of such device notifies the Secretary on an annual basis, in a manner prescribed by the Secretary, of the manufacture of such device. > > > #### “(3) Guidance > > Not later than 2 years after the date of enactment of this section, the Secretary shall issue final guidance on replication of multiple devices described in paragraph (2)(B).” > .
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