Regulatory Briefs: Microbiology Panel Meeting; Advisory Committee Nomination Portal
This article was originally published in The Gray Sheet
Executive Summary
FDA’s Microbiology Devices Panel advisory committee will vote on Roche’s cobas HPV Test as a first-line screening test. The agency launched an advisory committee nomination portal and sought nominations for certain device advisory panels. More regulatory news.
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Regulatory Briefs: FDA Device Reclassifications, Meetings Announcements
FDA proposes class II for nonthermal shortwave therapy devices and updates regulations to reflect class II designation for neuropsychiatric assessment device. Meetings on manufacturing quality, clinical trials and medical countermeasures announced. More regulatory news.
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.
Regulatory News In Brief
Lawmakers urge OMB to release unique device identifier rule. FDA selects device firms for early feasibility study pilot. More regulatory briefs.