Amended Economic Impact Analysis of Final Rule Requiring Use of Labeling on Natural Rubber Containing Devices

The Food and Drug Administration (FDA) is issuing an amended economic analysis statement relating to a final rule that published in the Federal Register of September 30, 1997 (62 FR 51021), requiring labeling statements concerning the presence of natural rubber latex in medical devices. This rule was issued in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber. The final rule becomes effective on September 30, 1998. In order to allow further comment on the economic impact of the September 30, 1997 final rule, FDA is publishing an amended economic impact statement, including an amended initial regulatory flexibility analysis (IRFA) that it has prepared under the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement and Fairness Act (SBREFA). FDA will respond to comments to this amended economic analysis statement, and publish in the Federal Register an amended final economic impact statement prior to the effective date of the September 30, 1997 rule.