How to Meet FDA Medical Device Recall Requirements - recall management software services and solutions

The last thing you need during a global pandemic is to deal with a medical device recall. Whether a correction or complete removal from the market, a single medical device recall can cost up to $600 million. The U.S. Food and Drug Administration (FDA) has strict guidance on how and when a recall should be initiated.

It’s a lengthy process that involves a lot of moving parts. Thankfully, there’s a solution on the market to make medical device recall more manageable – Trievr works to remain FDA compliant while relieving common pain points and managing multiple recalls. Let’s dive into how it works.

FDA Medical Device Recall Management Requirements

The FDA can legally require a company recall a device if it poses a significant health risk, including death. However, voluntary recalls are much more common. Even though you’re doing it voluntarily, you still need to notify the FDA, so it can monitor the recall process for compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act.

The FD&C Act covers a variety of sectors, including medical devices, which are divided into three distinct classes:

I: Medical devices that don’t require FDA approval but must follow general controls, like elastic bandages, enemas, and dental floss.

II: Medical devices that must be cleared using the FD&C Act’s 510(k) process. This includes hearing aids, powered wheelchairs, and some pregnancy kits.

III: Medical devices undergo a Premarket Approval (PMA) process like pharmaceuticals. This includes anything implanted, like pacemakers and breast implants.

Any firm responsible for a recall must submit a written report within 10 days outlining the corrective actions taken. Full device information and any related injury or illness must also be reported, and that’s just notifying the government.

You also need to keep your customers informed every step of the way. The FDA posts public notices of recalls, but you’ll create a stronger customer relationship by managing it yourself and keeping them in the loop. That’s where automated recall management comes into play.

Automating Recall Management Compliance

Lives are at risk with any product recall, but it’s especially true with a medical device recall. Everything needs to be handled quickly and efficiently using an assembly-line process. This simply isn’t possible without digitizing the entire platform and using powerful cloud-based analytical tools to increase response rates and maintain all documentation needed for FDA compliance.

Many firms simply don’t have the resources to complete this process and involve tedious emails, spreadsheets, and meetings. Meanwhile, fast-paced deadlines continue to pound you, putting stress on already thinly stretched resources.

Automation makes things easier by enabling mass data import and upload into convenient databases. From here, templates enable easy workflow throughout the project management process. Alerts, analytics, and reporting are all managed automatically, keeping all stakeholders informed and freeing resources for more high-level analytics.

Best of all, everything is contained in one intuitive dashboard that provides at-a-glance access to both top-level and detailed data. Recall progress can be tracked from the recipient response to product disposition, return/replacement, and completion. All details are taken care of, so you’ll save millions on your overall recall process.

Of course, the best usage of resources is to utilize a software-as-a-service (SaaS) platform for your recall management. This is why Trievr created a custom solution built from the ground up to serve the medical device industry. In fact, let’s discuss the premium benefits we provide to ensure your recall process runs smoothly from front to back.

Implementing the Best Way to Recall Medical Devices

There are two categories of actions the FDA considers an official recall: correction or removal actions. Some examples of actions that fall into the correction category are repairs, inspection, adjustments, and relabeling, along with notifying patients and monitoring them for health complications.

Meanwhile, destroying a device removes it from the market entirely, because it represents a health hazard. Products that fail to abide by all FDA rules and regulations above, or even potentially violate these legal requirements, will trigger a recall. It’s a good idea to keep an eye on any official press releases from the FDA, as they may pertain to your company.

You don’t even need to wait until a recall hits – you’re welcome to contact Trievr at any time to discuss the steps for your Enterprise Risk Management process. Our on-demand SaaS recall management device platform can easily scale up or down to handle any size or number of recalls.

We can set up a toll-free consumer hotline for you, develop custom return kits, and send first response and no-response letters through physical mail for anyone who can’t be reached via electronic methods. We offer free training and set-up, along with full support for your staff. There’s no aspect of the recall management process we can’t handle.