Regulatory News In Brief
This article was originally published in The Gray Sheet
Upcoming workshop will help manufacturers understand when they should submit a new 510(k) for changes to an existing product. CDRH plans to extend early feasibility pilot until May 2014. More regulatory news.
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An FDA device reviewer and an agency toxicologist talk to The Gray Sheet about key industry considerations for biocompatibility testing, emphasizing a growing focus on testing absorbable implants and testing for allergens in devices.
FDA reviewers ask manufacturers to put novel materials in devices through additional testing beyond what is described in existing guidance documents.
FDA issues two FDASIA-mandated reports to Congress – one on underrepresented subpopulations and the second on small businesses. More regulatory news.