ARTICLE SUMMARY:
CDRH officials took to the journal Health Affairs to press Congress for more authority to require device firms to disclose supply chain disruptions to head off product shortages.
Agency officials took to the journal Health Affairs on May 22 to press Congress for more authority to require device firms to disclose supply chain disruptions to head off product shortages. During the COVID-19 Public Health Emergency (PHE), Congress gave FDA express authority to mandate such reports (which are called “506J notifications”) for critical devices, but that power went away May 11 with the PHE expiration (and will only reactivate when a future PHE is declared). “We believe that even outside of a PHE manufacturers of critical medical devices should continue to notify the FDA of shortages. Currently, however, such notifications are voluntary,” Suzanne Schwartz, MD, who directs CDRH’s Office of Strategic Partnerships and Technology Innovation, and Tammy Beckham, who oversees the center’s Resilient Supply Chain and Shortages Prevention Program, wrote May 22 in the influential health policy journal.
FDA has been pressing for permanent disclosure authorities frequently over the past year, during congressional hearings and elsewhere. Industry officials say they are skeptical about the cost-benefit of the additional burdens. “We are committed to pursuing a least burdensome approach to 506J notifications for only the most critical devices, and only for circumstances that are likely to lead to a meaningful disruption in the supply of the device,” Schwartz and Beckham write.