Regulatory News In Brief
This article was originally published in The Gray Sheet
FDA issues guidance documents on PMA and 510(k) user fees and refunds. Agency issues proposed order for three pre-amendment devices. More regulatory news.
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U.S. District Court rules in FDA’s favor on 510(k) clearance rescission. Gastroenterology & Urology Devices panel to meet in June. More regulatory news.
CDRH Director Jeffrey Shuren detailed last week how federal sequestration cuts to FDA are impacting specific device center programs, including training, standards development and regulatory science. Shuren also signaled imminent policy releases from the center, including a finalized post-market surveillance plan.
FDA released a final rule on protections for children in clinical trials and a final guidance on financial disclosures by investigators. More regulatory news.