Q: Are there any FDA regulations or requirements that cover the tracking and recording of exchanged parts used in equipment such as medical devices?
A: The current answer depends on whether you are servicing the device, remanufacturing it, or refurbishing it.
If servicing a medical device by the OEM, then yes — there are specific regulations under 21 CFR Part 820.200, Servicing. These regulations apply to routine servicing of a device by the manufacturer of that device. They also apply to third-party servicers and to the services they perform independently or under contract to the OEM.
If while servicing a device, you change out parts, you should document that action. You also should document how you dispose of the part being replaced.
You are not required to record serial numbers for a part, unless that part is an essential design output.
You are not required to record serial numbers for a part — unless that part is an essential design output. As you may know, an essential design output indicates the item is essential for the proper functioning of the device and therefore is a high-risk part. Thus, it requires a higher level of control.
Regarding remanufacturing or refurbishing (and also reconditioning, rebuilding and remarketing):
FDA has long been concerned about the quality, safety, and continued effectiveness of devices that have been subject to these activities.
In the latest development, the Agency published a Federal Register notice in March 2016 requesting comments from stakeholders to help FDA consider some new regulations or guidance for these kinds of activities.
The comment period closed in June 2016. Later in the year, FDA held a public meeting to gather input, especially regarding specific definitions of each activity.
To date, the Agency has announced no further actions or regulations.
That means the current definition of a remanufacturing under 21 CFR 820.3(w) remains:
“A remanufacturer is any person who processes, conditions, renovates, repackages, restores or does any other act to a finished device which has been previously distributed to significantly change the finished device’s performance or safety specifications or intended use. [my emphasis added]
Furthermore, in FDA’s internal QSR guidance for investigators, FDA says:
“Remanufacturers are considered manufacturers. As such, these manufacturers are subject to inspection by FDA and shall meet the applicable requirements of the medical device QS regulation…” as well as MDR requirements, device tracking requirements, registration and listing, and premarket approval or clearance requirements.
So if you meet the definition of a remanufacturer, you need to exercise the same level of control as an OEM under the Quality System Regulation (21 CFR Part 820).
Finally, let’s discuss refurbishing. When refurbishment is done by the OEM, it’s covered by the QSR.
But third-party refurbishers, reconditioners, servicers and “as is” resellers of used devices currently are not subject to the requirements of the QSR.
The key to this non-regulation is the understanding that refurbishment should only restore the finished device to its original performance, safety specifications, or intended use. The assumption is that refurbishment should not significantly change any of these attributes.
My advice — for now — is that if you are a refurbisher who is not the original manufacturer, keep a watchful eye out for possible FDA regulatory developments during the next year or two. In the meantime, exercise a level of control commensurate with the risk of the product.
Answered by Denise Dion, Vice President of Regulatory and Quality Services for EduQuest, who served 18 years at the U.S. FDA as an expert field investigator and who was a member of FDA’s Design Control Inspection Strategy team. Denise is the lead instructor for EduQuest’s two-day training class, QSR Compliance Basics: Complying with FDA’s 21 CFR Part 820 Medical Device Quality System Regulation.