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Pediatric Device Reforms Presented To Policymakers By Advocacy Groups

This article was originally published in The Gray Sheet

Executive Summary

Firms modifying devices for pediatric patients should receive fast-tracked product review, according to a proposal generated by two children's organizations and other stakeholders

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CED is coming soon: Revised draft guidance on CMS' coverage-with-evidence development policy is expected out within "weeks," agency Administrator Mark McClellan said June 15 at the Medical Device Manufacturers Association annual meeting in Washington, D.C. Despite rumors following the first draft guidance that CED was dead in the water due to concerns about basing coverage on patient consent, the new version will address the issue (1"The Gray Sheet" May 8, 2006, p. 7). "We want to get this right," McClellan said...

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CED is coming soon: Revised draft guidance on CMS' coverage-with-evidence development policy is expected out within "weeks," agency Administrator Mark McClellan said June 15 at the Medical Device Manufacturers Association annual meeting in Washington, D.C. Despite rumors following the first draft guidance that CED was dead in the water due to concerns about basing coverage on patient consent, the new version will address the issue (1"The Gray Sheet" May 8, 2006, p. 7). "We want to get this right," McClellan said...

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