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Apr
09

Expedited Medical Device Review Leading to More Recalls

The faster a new medical device is approved, the sooner it’s likely to be recalled, according to a new research letter published in JAMA Internal Medicine. While the authors admit the data and findings have limitations, two conclusions they draw are startling:

  1. Medical devices approved by priority review were twice as likely to be recalled.
  2. Devices that received a priority review were recalled 6.5 months sooner once they entered the market.

Think about those for a minute. It’s easy for consumers and regulators to blame the companies designing and marketing these products. But the fact is, these findings have little to do with the decisions of the research and development teams or company leadership. Instead it’s the nature of the products – new, groundbreaking devices that meet complex medical challenges.

As noted in a Regulatory Focus article from the Regulatory Affairs Professionals Society, “FDA has long acknowledged that devices that qualify for expedited reviews may take longer to review, as they are often more complex and raise novel scientific issues.” But the goal of the program is to provide patients with faster access to breakthrough devices.

In response to these initial findings, however, there are lessons companies and regulators can act upon. When it comes to actions medical device manufacturers should:

  1. Learn from other companies’ mistakes. While your device may be groundbreaking, the potential safety issues patients could face likely aren’t as unique. Keep a close eye on why other products were recalled, and consider that as you research, develop and take new products to the market.
  2. Plan for that recall. Ideally you will never need to execute on your plan. But now’s the time to make sure it’s buttoned up. Especially now that these findings are on the radar of FDA and other stakeholders who are seeking changes to the program in the name of patient safety.
  3. Be prepared for additional regulatory changes. We see little changing during the coronavirus pandemic, but things will settle down eventually. When they do, the research letter authors want FDA to strengthen patient protections for devices that qualify for the breakthrough device program, including “identifying appropriate safeguards during the approval process, strengthening post-market surveillance to allow prompt identification of safety concerns, and increased availability and transparency of adverse event reports.” Be ready for those changes when they start to gain traction.

You have your work cut out for you in responding to current customer and patient needs. But you need to add one item to your list: Preparing for a possible recall when patients’ fears and concerns are at their highest.

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