Passed in 2012, the user fee authorization of the Food and Drug Administration Safety and Innovation Act excludes this guidance and stipulates that the guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device,” dated January 10, 1997, shall apply until the promulgation of a new guidance:
SEC. 604. DEVICE MODIFICATIONS REQUIRING PREMARKET NOTIFICATION PRIOR TO MARKETING.
Section 510(n) (21 U.S.C. 360(n)) is amended by--
‘(B) The Secretary shall withdraw the Food and Drug Administration draft guidance entitled ‘Guidance for Industry and FDA Staff--510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device’, dated July 27, 2011, and shall not use this draft guidance as part of, or for the basis of, any premarket review or any compliance or enforcement decisions or actions.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‘(i) any draft guidance or proposed regulation that addresses when to submit a premarket notification submission for changes and modifications made to a manufacturer’s previously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.’
Written by Jeremy Petitpez, a student at the Paris Bar School.