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Experts: Proposed Redesign of Form 483 Could Pose Threat to Trade Secrets

December 14, 2009
An FDA Transparency Task Force request for comment on making Form 483s more accessible is taking heat for both the way it was announced and the possible threat it could pose to industry trade secrets. The request did not come through traditional channels but was announced last month in a blog entry on the task force’s website and a CDRH Twitter post. In redesigning the forms to make them more public, the FDA could let trade secrets slip through, Seth Mailhot, a former FDA inspector and compliance officer and attorney at Nixon Peabody, said.
Devices & Diagnostics Letter