Regulatory News In Brief
This article was originally published in The Gray Sheet
J&J's Sedasys appeal docket
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CDRH’s Office of Device Evaluation creates a chief medical officer role to improve consistency in clinical policy, among other recent staffing changes.
FDA’s plan for improving its 510(k) pre-market submission program includes clarifying instances where clinical data should be included and streamlining its “de novo” review process for certain innovative, lower-risk devices.
Johnson & Johnson subsidiary Ethicon Endo-Surgery has received a go-ahead from the FDA commissioner's office to embark on a rarely used process to appeal a PMA denial by the agency’s device center.