Dive Brief
Nearly three years after publishing draft guidance, the FDA has changed the title and added a section on the regulatory requirements for remanufacturers in the final version of the text.
Dive Insight
The FDA published draft guidance in 2021 to clarify the distinction between device remanufacturing and servicing. Many reusable medical devices are serviced. Previously, it was unclear when servicing became so extensive that it qualified as remanufacturing.
The draft defined remanufacturing as an act done to a finished device that significantly changes the performance, safety or intended use, including renovating, repackaging or restoring products.
Conclusion
The FDA updated parts of the draft text, for example to explain that modifying the design of a printed circuit board or temporarily breaking a seal to replace a component may significantly change safety and performance specifications.
