Medical device manufacturers are playing with fire if they fail to identify a particular customer’s feedback as a Medical Device Report (MDR) or let complaints fall by the wayside, according to investigators for the US Food and Drug Administration (FDA), who also say they’re concerned about the burgeoning outsourcing of complaint handling.
During recent inspections, “I’ve run into outsourcing, and in this day and age, we’re getting a lot more virtual companies and everyone has their hands in something or other,” said Laureen Geniusz, a consumer safety officer in the FDA’s Office of Medical Device and Radiological Health Inspectorate (OMDRHI) within the agency’s Office of Inspections and Investigations (OII). (Related Story: “FDA Investigator Reminds MedTechs: Monitoring of Suppliers Must Include Risk Considerations,” QualityHub, May 27, 2025.)
“But just remember, if [the outsourcing of complaint handling activities] happens, … someone must be responsible for the complaint handling portion of the regulations,” she said. “So, if you’re 100 percent outsourcing complaints – and there’s nothing that says you can’t do that – [FDA investigators] would probably look [at] how you are handling [complaints during] audits. How is the training happening [around complaints]? So, it is extremely important that you consider these things, too. Just because [complaints] get outsourced to all these different people or companies, the regulations still apply. We just have to figure out who they apply to.”
Geniusz’s comments came during an “investigator insights” panel at MedCon 2025. Also during the panel discussion, OMDRHI Senior Operations Officer Katelyn Staub-Zamperini confirmed that the outsourcing of complaint handling functions and MDR reporting is a rapidly growing trend that investigators are seeing in the field.
“From what I’ve seen, most firms are doing this for efficiency and to streamline efforts,” Staub-Zamperini said. (Related Story: “FDA Investigators: Design Creep, Software Changes, Social Media Influencers Challenge MedTech Firms,” QualityHub, June 6, 2025.)
“The biggest concern, I’d say, is that it opens the room for questions surrounding responsibility, and it leaves the potential for a lot of things to fall through the cracks. Like I mentioned, a big effort around this is the efficiency and streamlining of efforts, which is absolutely fine, but responsibility really needs to be nailed down. Responsibility is key.”
Make Sure Customer Feedback Evaluated as Potential Complaint
Meanwhile, fellow OMDRHI Senior Operations Officer Tom Peter said during the MedCon panel discussion that FDA investigators routinely uncover situations where customer feedback is not being evaluated to determine whether there are any complaints. (Related Story: “FDA Investigators Highlight Common Design Control Problems Seen During Facility Inspections,” QualityHub, May 29, 2025.)
“A company I was inspecting, their procedures allowed for their call center to make the decision as to whether the feedback that was being received was either a complaint – [which means it meets] the definition of a complaint per our regulation – or what they called an ‘inquiry.’ And these two different types of records were housed in two different places in their QMS,” or quality management system, Peter explained.
“When we see something like this in your procedure, we know better than to simply ask for a complaint log,” he added. “We’ll often ask for a log of – in this particular case – the inquiries as well, because we know how common of an issue this is, so we’ll go and look at those inquiries. And as it turned out, a lot of those [inquiries] met the definition of a complaint. …So, in this case, a lot of complaint records weren’t being generated. The complaint handling process wasn’t being kicked off. There was no investigation that we would expect to see that comes with that complaint handling process.”
And to “make things worse,” Peter said, this company wasn’t feeding inquiries into its corrective and preventive action (CAPA) system to check for recurring inquiries – which were, indeed, complaints.
“There were some recurring issues in this case where [inquiries] weren’t being triggered as complaints and then there was no corrective action being taken in response because that quality data source was not being considered,” he said. “So, yeah, lot going on there.”
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