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510(k) summary/statement reg

This article was originally published in The Gray Sheet

Executive Summary

FDA final rule, expected to issue this month, will revise an April 1992 interim rule to ensure that confidential or proprietary information is not released, according to agency staffers. The reg will spell out requirements for either submitting a summary of safety and effectiveness information with a 510(k) or submitting a statement that the information will be made available upon request. The reg also will cover requirements that Class III 510(k)s include summaries of and citations to safety and effectiveness information. In May 1992, the Health Industry Manufacturers Association successfully petitioned the agency to delay implementation of its interim rule, in part over concerns that the proposal would have required release of confidential information ("The Gray Sheet" June 1, 1992, p. 11)
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