MedCon: Tips for navigating the device recall process

COLUMBUS, OH – Device recalls often take more than a year to complete, but device manufacturers can make that process smoother by providing regular status reports to the US Food and Drug Administration (FDA), being diligent about contacting affected customers and providing complete information about product corrections or destructions, according to FDA recall coordinators.

Two of FDA’s recall coordinators offered tips to get through the recall process with minimal confusion and back-and-forth with the agency during the 2023 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA.

Starting a recall

The recall process begins with a notification letter to affected customers. However, many device firms are not aware that FDA is available to review the letter before it goes out to customers, explained Meredith Andress, Division 2 Recall Coordinator in the Office of Medical Device and Radiological Health Operations Division in FDA’s Office of Regulatory Affairs (ORA).

Andress also advised firms not to assume the level of understanding of the recipient. The letter should be written to make clear to anyone reading it that it involves an “urgent medical recall,” she said. The letter should also provide clear information on what actions the customer should take and how quickly they need to act.

FDA recommends including photos of the device or the device labeling for faster identification during a recall. “Your customers should be able to easily and quickly identify the affected product,” Andress said.

Device firms also need to report the recall to FDA through an 806 report, she said. One common point of confusion about the report is the difference between the “top firm official” and the “recall contact.” Andress said the “top firm official” is the person who will be used for all official correspondence from the FDA, while the “recall contact” is the point person who the agency will contact concerning specific questions.

The 806 report also asks firms to report an “awareness date,” which is the date that the company became aware of the issue prompting the recall, not when they realized the necessity for the recall itself. That could be when the firm received the first complaint, for instance, Andress said.

The 806 report is also where device firms will submit a recall strategy, outlining specific plans to address the affected product. “It needs to be clear, it needs to be specific, and it needs to be detailed,” Andress said. “I want to know exactly what you’re doing.”

Including detailed information on the recall strategy at this stage will limit the amount of back and forth with the agency, Andress said. Once the 806 report is reviewed by ORA, it is sent to the Center for Devices and Radiological Health (CDRH) for a formal classification of the recall.

Status reports

One of the key steps in a device recall is providing monthly status reports to FDA to show how the firm is progressing through its recall strategy, said Cynthia Aycock, Division 1 Recall Coordinator in the Office of Medical Devices and Radiological Health Operations in ORA.

Status reports should include details on the effectiveness of the firm’s customer notification, the number of products corrected or removed (even if the corrective action is a software update), and the estimated date of completion of the recall. “If [the estimated completion date] changes, it’s fine. This is just so that we know about how far in your process are you,” Aycock said.

If there are changes to the recall strategy, such additional customers added or changes in destruction plans, those should be included and explained in status reports. However, if the firm expands the recall, the agency should be notified immediately, Aycock said.

Terminating a recall

FDA cannot terminate a recall until the products are corrected or removed from the market, Aycock said. When making a termination request to FDA, firms must include the final status report with the overall response rate of customers and the breakdown of the number of devices corrected or removed. The termination request should also include the final disposition of returned products, the root cause of the recall, and all corrective and prevention actions undertaken.

Part of the termination process includes an effectiveness records check, which evaluates whether the customer received the recall notice and took the recommended actions. FDA often receives questions from device firms about how to show effectiveness and what to do if they are unable to reach all affected customers, Aycock said.

Firms can demonstrate effectiveness through completed customer response forms, records of service, product return records, and communication with customers through email or call logs. Read receipts or certified delivery receipts do not, on their own, show effectiveness, Aycock said. “You can’t use it as proof positive that your customer was notified,” she said.

Aycock said the agency recommends a combination of outreach methods. A “good faith” effort typically includes at least three attempts to contact customers using two or more methods, such as mail, email, phone calls, or an in-person visit. Some firms have also had success with online recall portals, she said. “Make sure you space those out reasonably [and that] you’re not just robocalling the same person three times in the same afternoon. We’ll see that and we’re going to ask questions,” she said.

If the response rate remains low after making a good faith effort, be prepared to discuss the issue with the recall coordinator at the time of termination and explain why the response rate was low, who was contacted, and if there were extenuating circumstances that complicated the process, she said.

MedCon: Tips for navigating the device recall process

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