What will 2022 hold?

Projecting into the now unfurling year, Sedgwick anticipates regulation and enforcement to increase across industries. What follows are specifics for the five key industries studied:

Auto: Additionally safety and regulatory challenges are in the future for automakers as vehicle technology is increasingly being deployed. Further, autonomous and electric vehicles will become bigger considerations along with concerns around data privacy and connected cars, safety of new technology and new crash safety features.
Consumer products: The Consumer Product Safety Commission (CPSC) is looking for ways to make reporting easier for manufacturers, but it is not showing signs it will soften its stance on compliance and enforcement. The CPSC has also signaled a commitment to ensuring businesses take an all-inclusive approach when notifying consumers about recalls.
Food recalls: While it is unclear how the Foodborne Outbreak Response Improvement Plan from the Food and Drug Administration (FDA) will change reporting and tracing regulations, Sedgwick cautioned businesses should review the guidelines and start planning for how their companies' operations and reporting structures might change.
Pharmaceuticals: Sedgwick anticipates more Emergency Use Authorization (EUA) to be issued by the FDA in an attempt to end and contain COVID-19. As pharmaceutical companies seek emergency authorization, Sedgwick said it is important to not rush through any compliance and recall preparedness steps. Further, these businesses should prepare for a post-pandemic world by making plans for how they will transition from EUAs to normal regulatory approvals.
Medical devices: Regulators in the medical device sector are showing concern over the growing number of cyber incidents affecting hospitals and health care systems. In addition to devices being a potential source for data and security breaches, Sedgwick reported there is also an added risk to patient care and health. The FDA is working to reinforce cybersecurity for the health care sector in a number of ways, including the creation of a leadership position focused on medical device serenity in the administration's Center for Device and Radiological Health.

"While the ongoing global health crisis continues, it seems that regulators across most market categories are looking ahead and starting to increase surveillance and enforcement," Chris Harvey, Sedgwick senior vice president, said in a release. "Businesses, especially those that made changes to their operations or suppliers during the pandemic, must be ready for more inspections and oversight. My advice is to review all recall management, crisis and communications plans now before the regulators come knocking."

Special Reports /

U.S. product recall events decline, but number of units impacted grows

Related Stories

Recommended For You