Business · 21/05/2001Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance for Medical Devices Monitoring Sterilizers in Healthcare Facilities
Summary
The FDA has released a draft guidance document outlining recommendations for medical device manufacturers submitting premarket notifications for biological indicators monitoring sterilizers in healthcare facilities, pending FDA review.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →