Guide on Product Shortage Reporting Responsibility

FDA has released a guidance on “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” During the Covid-19 pandemic, FDA has been closely monitoring the medical product supply chain to see how it may be impacted by the outbreak. The guidance discusses requirements on notifying FDA about a permanent discontinuance in the manufacture of certain products or an interruption in the manufacture of certain products that is likely to lead to a meaningful disruption in supply of that product in the U.S. The document also recommends that applicants and manufacturers provide additional details and follow additional procedures to ensure FDA has the specific information it needs to help prevent or mitigate shortages. Additionally, it explains how FDA communicates information about products in short supply.