ASHE provides clarification on FDA medical device guidance

FDA seeks comments on draft guidance for remanufacturing of medical devices by September 22, 2021 

Per the Food and Drug Administration (FDA), this draft guidance is intended to help clarify whether activities performed on devices are likely "remanufacturing." Such clarification intends to provide consistency and better understanding of applicable statutory and regulatory requirements.

Within the draft guidance, the FDA bases remanufacturing around the following definitions:

• Recondition/Refurbish/Rebuild: Restores a medical device to the original equipment manufacturer’s (OEM’s) original specifications or to be “like new.” The device may be brought to current specifications if the change(s) made to the device do not significantly change the finished device’s performance or safety specifications, or intended use. These activities include repair of components, installation of OEM provided updates and upgrades, and replacement of worn parts.
• Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.
• Repair: A type of servicing that returns a component to original specifications, including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device.
• Service: 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. Servicing excludes activities that significantly change the finished device’s safety or performance specifications, or intended use.

These definitions have an impact on what an organization or third-party servicer can do to a medical device, thus indirectly influencing the organization’s right to repair. While ASHE agrees with the FDA that changing a finished device’s performance/safety specifications or intended use would constitute remanufacturing, ASHE feels that the use of the word “significantly” within several of these definitions adds ambiguity to the guidelines. The FDA describes “significantly changing” under Section VI as follows:

For purposes of this draft guidance, FDA generally considers a significant change to device performance or safety specifications to be one that, based on verification and validation testing and/or a risk-based assessment, results in a finished device that is outside the OEM’s performance or safety specifications or introduces new risks or significantly modifies existing risks.

However, ASHE feels this definition could lead to subjective interpretation as to what constitutes significantly changing the finished device’s performance/safety specifications or intended use and thus the specific intention of the guidance remains ambiguous.

Based on this understanding, ASHE recommends that organizations submit comments to clarify the definition of “significant change.” The best way to do this is with real-world applications detailing a “significant change.” The FDA does provide several examples within the guidance document, and ASHE recommends that commenting organizations provide site-specific data regarding how often remanufacturing is performed by in-house service staff. This data will help the FDA better understand the impact of the proposed guidance being and if changes would be appropriate.

The guidance and online submission can be accessed on the FDA website. If you have any questions or would like more information, please contact ASHE’s Senior Associate Director of Advocacy Jonathan Flannery at JFlannery@aha.org.