Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
News on FDA workforce troubles, feedback on CDRH’s eCopy policy and more.
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Regulatory Briefs: MAUDE Replacement; Electronic Source Data Guidance; Social Media Monitoring
The device center plans to replace the MAUDE adverse events database system by the end of the year. Agency issues final guidance on electronic source data in clinical investigations. FDA purchases social media monitoring software to gauge the effectiveness of its online communications. More regulatory news.
FDA’s Revised Electronic Source Data Guidance Less Specific On How Data Should Flow
FDA issues its second draft on the topic in two years, going back to the drawing board after comments from industry, but BIO still hasn’t persuaded the agency to explicitly exempt electronic diaries.
FDA Finalizes 510(k), PMA, eCopy Guidances
FDA spells out its acceptance policies for 510(k) and PMA submissions, as well as guidelines for submitting electronic copies of submissions. The guidances all aim to make the device review process more efficient and speedy.