Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem

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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem.'' The guidance, which is included in this notice, is a Level 1 guidance that is immediately effective in accordance with FDA's good guidance practices (GGP's) criteria, which allow immediate implementation of guidance that is necessary for public health reasons. FDA will receive comments on the guidance at any time and consider them in determining whether to amend the current guidance. DATES: This guidance is effective June 24, 1998. Submit written comments by September 22, 1998. After the close of the comment period, written comments may be submitted at any time to Thomas B. Shope (address below).