The changes in compliance dates for devices that are implantable, life-saving, and life sustaining, are under the changes to section 519(f) of the FD&C Act made by section 614 of FDASIA.
The provision in the rule requiring dates on device labels intended to be brought to the attention of the user to appear in a particular format is issued under the authority of sections 502(a), 502(c), and 701(a) of the FD&C Act. The requirement for a uniform date format will ensure dates on device labels intended to be brought to the attention of the user are not misleading, and to the extent these dates are required to appear on the label, ensure that they are likely to be understood by the ordinary individual under customary conditions of use.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency finds that this final rule is an economically significant regulatory action under Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing "any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of
This final rule requires the label and packages of medical devices to bear a UDI and provides for alternative placement and exceptions for certain devices. In addition, this final rule requires certain devices to be directly marked with a UDI, with exceptions. Medical device records throughout the required device recordkeeping and reporting systems will need to be modified to include the UDI. Under this final rule,
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