FDA Remanufacturing Guidance – One Year Later
The Corner Office
Wayne Moore
5/13/2025
One year has passed since the FDA released its final Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff document — issued on May 10, 2024. For the purpose of this article, I will focus on the following portion of the FDA language used in this document:
“Servicing is the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use.12 As described in the FDA Report on Device Servicing, FDA’s authority to regulate the servicing of medical devices by any entity is grounded in the Agency’s authority to regulate medical devices and radiation-emitting electronic products under the Federal Food, Drug, and Cosmetic (FD&C) Act.
Simply stated, the above means: Even if you may identify as a servicer, your activities may not meet the FDA definition of servicing. The question each third-party servicer or ISO must ask itself is, “Do my repair activities align with the FDA guidance document?”
One key point in the guidance document relates to testing components, parts, and materials used in the “repair” process. The FDA states it this way:
“Assess component/part/material dimensional and performance specifications – Assessment of changes to dimensional and performance specifications can inform whether the activity performed is remanufacturing. The impact of component/part/material changes can be evaluated by comparison to the OEM components/parts/materials specifications and/or through verification and validation testing. Deviations in component/part/material specifications from the OEM’s legally marketed device may result in significant changes to the device’s performance or safety specifications, and may necessitate closer evaluation, such as conducting an engineering analysis, verification and/or validation testing, or a risk-based assessment, and consideration of the regulatory criteria describing when a new marketing submission is required.”
Verification and validation (V&V) testing requires objective data as a fundamental output of the test. At Acertara, we perform the same type of science-based objective testing as OEMs perform. As a matter of fact, multiple OEMs use our patented ultrasound probe test system, ATLAS (see test result image above), in their engineering development and in their manufacturing line. We test all probes repaired at Acertara using ATLAS data, matched against the performance of a fully functional in-kind probe to ensure post-repair substantial equivalence.
On the one-year anniversary of the release of the FDA guidance document, it is a reminder to all third-party servicers and ISOs to ensure their repair activities are aligned with the V&V guidance found in that document. Not to do so can put patients at risk, and it can result in a for-cause FDA facilities inspection.
Until Next Month,
Wayne