U.S. sector spotlight

For the medial device sector, the growing number of cyberattacks on hospitals and healthcare systems remains a concern for regulators. Not only are devices at risk of being the source of a data or security breach, but there is also an added risk to patient care and health. The FDA is responding to cybersecurity concerns in a variety of ways, including creating a new leadership position focused on medical device security within the FDA's Center for Devices and Radiological Health (CDRH).

And while we can’t declare victory yet over the COVID-19 pandemic, the FDA is starting to think about what happens next for all of the medical devices that were granted Emergency Use Authorizations (EUAs), or fell within special public health emergency enforcement. Another change that the pandemic brought to medical devices was 3D printing at the point-of-care (PoC). The FDA is gathering input on how to regulate this and where the responsibility and liability reside for devices produced outside a manufacturing facility. Companies will have to think carefully about whether the value of having a large quantity of products made quickly at the PoC outweighs potential legal liabilities.

While product recall numbers are important, they are only part of the story. Here's what you should take away from medical device product safety developments in 2022:

• Under the COVID-19 public health emergency, companies had some immunity from tort liability under the Public Readiness and Emergency Preparedness Act (PREP Act). Once the public health emergency is declared over, PREP Act immunity will disappear. Are you ready for the possibility of increased litigation for devices that were protected under the PREP Act? Have you reviewed your risk?
• For well over a year, the FDA has been urging medical device companies with products marketed under EUAs to begin transitioning to “normal” by submitting marketing applications. Have you heeded this advice? Have you considered the consequences of not doing so? Are you prepared for the agency to return to its normal premarket review process?