The United States Food and Drug Administration has provided expedited priority review for certain medical devices since 1994. The move is meant to shorten the lead time it takes for patients to access breakthrough devices. However, new research published in JAMA Internal Medicine seems to draw correlations between shorter review times and increased chances of recalls.
What’s even worse, the Regulatory Affairs Professionals Society notes that the FDA has long acknowledged these devices actually require a longer review time. Emerging technologies are complex with a lot of moving parts, and they need to be tested in a variety of situations. A faster priority review instead forces a condensed testing schedule, which puts companies in a precarious position, as your brand is attached to a costly recall.
Here’s everything you need to know about FDA medical devices.
Medical Technology Is Inhibited by Regulation
The purpose of the FDA is to protect public health by assuring our food, drugs, cosmetics, and medical devices are safe. FDA approval is required before selling any of these products on the public market, and that approval process takes 12 months to complete. That accounts for six months for the FDA clinical trials and another six months of on-site trials overseen by the institutional review board (IRB).
The pre-certification process is increasingly becoming streamlined, as the department works to accommodate the glut of medical devices flooding the markets. It classifies devices into one of three categories (Class I, II, and III) based on its specialty (i.e. Dental) and regulation citation.
Premarket approval is necessary to fully demonstrate the safety and effectiveness of a medical device. Of course, just because it’s not FDA approved doesn’t mean the device can’t be sold. Take wearable fitness trackers, for example.
Fitbit, Apple, and Samsung are among the industry leaders in wearable technology. This market grew from 38.65 million devices in North America in 2015 to an estimated 181 million devices in 2020. This is despite the FDA denying regulation of wearable fitness trackers as medical devices in 2016. It wasn’t long after that Fitbit and the other manufacturers started pouring lobbying money into changing the FDA’s mind.
Even the process to begin implementing software-based clinical trials required several years to fully adapt to the FDA’s stringent testing regulations. While all these measures are necessary to ensure consumer safety, wearables have been on the consumer market for a decade and are now ubiquitous. It would be unacceptable for them to be fully ignored. This is why the expedited process was put into effect, but it may be detrimental to businesses if it causes a medical device recall.
The Cost of an FDA Device Recall
If you think the FDA approval process is long, the recall process is even longer. In fact, a recall can take several years and cost the medical device industry up to $5 billion every year. McKinsey even points out that a medical device company loses up to 10% drops in stock prices on average due to a recall. Meanwhile, the 2010 recall of Boston Scientific’s implantable defibrillator cost the company $5 million per day.
Of course, these financial burdens are nothing compared to the potential loss of life associated with defective medical devices. Compliance with regulations like section 820 of FDA guidelines means fully tracing the operational supply chain of your product. That also includes during a recall, when a variety of reporting must be done to ensure consumers are fully protected.
So, what can companies do to ensure they maintain regulatory compliance and avoid recalls?
How to Avoid an FDA Recall
The recent JAMA study suggests that medical devices approved by priority review are 2x more likely to be recalled. They’re also recalled a median of six and a half months earlier than other recalled products. This extends across the spectrum of recall classifications, including Class 1 recalls, which is the most serious, and priority-reviewed devices were recalled 9.5 months sooner.
What’s more – the study’s authors state that medical device makers are likely to pursue priority review as often as possible, as has been seen in drugs and biologics. This leaves three lessons for businesses to learn.
1. Others’ Mistakes Are Your Opportunity
No matter how groundbreaking and innovative your device is, it’s inevitably treating a category of patient. It would behoove you to keep an eye on all device recalls, but especially those in your arena. This proactive approach can drive your research and development toward a better solution, which brings us to the next point.
2. Continue Research and Development
A shorter pre-market approval process doesn’t mean you should cut corners on product development. Continue pushing the boundaries and staying on top of all regulatory changes that may impact your company. Of course, no plan is ever perfect.
3. Brace for a Recall
No matter how much care you take, you need a contingency plan in your enterprise risk management (ERM) strategy to account for a recall. This means you need a scalable solution that can be easily used when you need it.
This is where Trievr comes in. Our SaaS recall management solution can automate the entire medical device recall process. Contact us today to learn more about our out-the-box solutions.