Any complaint involving alleged failure of a device, its labeling or its packaging must be investigated.
Due to new guidance, these records must now include the unique device identification and the unique product code, Ombu Enterprises President Dan O’Leary said during a recent FDAnews webinar. The following Q&A with O’Leary was excerpted from the webinar:
Question: Must the unique device identifier number be listed as part of the complaint file, or is it acceptable to reference the location of the UDI number, such as the label?
Answer: The requirement is that the complaint file contain specific information, and it could either be written in the file or you can point to it. But the problem is that if you point to the label then, depending upon how you set up your UDI, the label may change with every lot. The device identifier portion may stay constant, but the date of manufacture, the lot number, and the serial number are going to change dynamically. And so you would have to point to exactly the correct label. That’s probably not going to work unless you can point to the unique label that’s represented in your system. But if you can do that, then a pointer would be acceptable.
Q: What happens if at the date of a complaint no information has been provided that alleges that a complaint may be reportable but the information is provided 10 days later? Which date is valid for reporting purposes?
A: It’s going to be the date you become aware. What typically happens is that the FDA investigator is going to say that you have 30 days in order to make your initial report, and the 30-day clock is going to start when you receive the complaint. But it may be that you become aware after the investigation, so you would need to document the date when you became aware, and then that’s when the clock starts. And then you have 30 days in order to submit.
I recommend that you don’t take the full 30 days. Because now you’re submitting eMDRs, and you’ve got to go through the gateway, which means if the system goes down or there’s a hiccup, you’re going to have to troubleshoot that.
Q: What other feedback sources should be considered for postmarket risk management besides complaints?
A: When you get a complaint you know about your devices, but it can be helpful to know what your competitors are up to. You can go to the FDA’s website and access Total Product Life Cycle reports, and you can analyze the complaint codes that are showing up in MDRs.
You want to analyze any recalls to see whether or not the reason that somebody else has initiated a recall could apply to your company. The TPLC report is full of hyperlinks, so you can see how often certain problem codes are occuring. It’s sorted so that the most frequent occurrences are at the top. From those hyperlinks you can get to any individual MDR report or any individual recall report. So, that’s probably the most powerful source.
Q: How important is it that manufacturers institute the UDI system for traceability?
A: Requirements for the manufacturer are that you have to include it on all your labels, and that’s part of labeling inspection. It’s included in the device history record, the master device record and all of the complaint files. And it’s included in any corrections or removals reports that you make. So, what this means is that UDI as a manufacturer is going to hit all of those systems, and you are supposed to have them all implemented.
This means that if you have information in an old system you’re going to have to create fields to hold that information, and those fields are then going to be part of a software package that gets validated. A lot of companies are finding this to be a relatively large task. But FDA investigators are going to start checking, particularly after Sept. 24, for Class II devices.