Business · 31/10/2006Updated: 10/17/2026 · 1 min read
FDA Publishes Draft Guidance for Absorbable Hemostatic Device
Summary
The FDA has released a draft guidance document outlining how an absorbable hemostatic device can meet the requirements for special controls under the Class II device category, in preparation for a proposed rule to reclassify the device from Class III to Class II.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →