Sec. 604. DEVICE MODIFICATIONS REQUIRING PREMARKET NOTIFICATION PRIOR TO MARKETING
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## SEC. 604 DEVICE MODIFICATIONS REQUIRING PREMARKET NOTIFICATION PRIOR TO MARKETING Section 510(n) (21 U.S.C. 360(n)) is amended by— ####
(1)striking “(n) The Secretary” and inserting “(n)(1) The Secretary”; and ####
(2)by adding at the end the following: > > #### “(2) > > > #####
(A)> > Not later than 18 months after the date of enactment of this paragraph, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report regarding when a premarket notification under subsection
(k)should be submitted for a modification or change to a legally marketed device. The report shall include the Secretary’s interpretation of the following terms: ‘could significantly affect the safety or effectiveness of the device’, ‘a significant change or modification in design, material, chemical composition, energy source, or manufacturing process’, and ‘major change or modification in the intended use of the device’. The report also shall discuss possible processes for industry to use to determine whether a new submission under subsection
(k)is required and shall analyze how to leverage existing quality system requirements to reduce premarket burden, facilitate continual device improvement, and provide reasonable assurance of safety and effectiveness of modified devices. In developing such report, the Secretary shall consider the input of interested stakeholders. > > > ##### “(B) > > The Secretary shall withdraw the Food and Drug Administration draft guidance entitled ‘Guidance for Industry and FDA Staff—510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device’, dated July 27, 2011, and shall not use this draft guidance as part of, or for the basis of, any premarket review or any compliance or enforcement decisions or actions. The Secretary shall not issue— > > > ###### “(i) > > any draft guidance or proposed regulation that addresses when to submit a premarket notification submission for changes and modifications made to a manufacturer’s previously cleared device before the receipt by the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate of the report required in subparagraph (A); and > > > ###### “(ii) > > any final guidance or regulation on that topic for one year after date of receipt of such report by the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate. > > > ##### “(C) > > The Food and Drug Administration guidance entitled ‘Deciding When to Submit a 510(k) for a Change to an Existing Device’, dated January 10, 1997, shall be in effect until the subsequent issuance of guidance or promulgation, if appropriate, of a regulation described in subparagraph (B), and the Secretary shall interpret such guidance in a manner that is consistent with the manner in which the Secretary has interpreted such guidance since 1997.” > .
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Sec. 604
DEVICE MODIFICATIONS REQUIRING PREMARKET NOTIFICATION PRIOR TO MARKETING
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