Understanding FDA’s Latest Rules on Medical Device Maintenance

AGG Food & Drug practice chair Alan Minsk authored an article titled “Understanding FDA’s Latest Rules on Medical Device Maintenance” for 24×7 Magazine.

Alan details FDA’s recently issued Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff, which serves as a warning to those involved in the servicing of medical devices, emphasizing the need for vigilance and adherence to regulatory frameworks.

“Servicing medical devices is critical to their proper usage, but some industry groups raised concerns about the quality of servicing provided by third-party entities that are not regulated by the FDA,” Alan said. “As a result, FDA developed this guidance to provide a framework for classifying activities performed by entities as ‘servicing’ or ‘remanufacturing’ of reusable medical devices.”

Alan also suggests that companies carefully document and evaluate whether the individual and cumulative effect of activities performed on devices is remanufacturing or servicing, utilizing the guidance’s principles, flowchart, and examples.

To read the full article, please click here.