Special 510(k) proposal's requirement for design control activities summary too burdensome -- J&J.
This article was originally published in The Gray Sheet
Executive Summary
SPECIAL 510(k) POLICY's SUMMARY OF DESIGN CONTROL ACTIVITIES requires an "unprecedented" level of "detailed GMP information," Johnson & Johnson asserts in Nov. 18 comments to FDA. The content requirements for the design control summary stipulated by the agency move the 510(k) review process "in the wrong direction," J&J says.