Remanufacturing of Medical Devices Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff Document issued on May 10, 2024.
Summary for Acertara customers The FDA guidance issued last week is a fresh and clarifying look at how to distinguish between repair and remanufacturing. The guidance document seeks to help companies engaged in these activities to understand how to interpret the existing laws that govern repair and remanufacturing. One key takeaway for Acertara customers is … Continue reading
