An updated guidance from the US Food and Drug Administration (FDA) clarifies how the agency is handling device shortages and cessation in manufacturing during the public health emergency of the COVID-19 pandemic.
The FDA’s Center for Devices and Radiological Health updated the guidance, entitled “Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency,” so that the agency can have the information it needs to prevent or mitigate shortages.
Section 506J of the Food, Drug & Cosmetics (FD&C) act requires that FDA maintain an up-to-date list of medical devices in shortage, including those that are no longer being made. The guidance includes a sample 506J notification form that manufacturers can use to provide FDA with statutorily required information about shortage or discontinuation of manufacture.
In the updated guidance, FDA clarifies what factors it uses to determine whether a device is in shortage. Among the indices of shortage are signs of supply disruptions such as 506J notifications, or voluntary notification by manufacturers; the agency will also look for signs of distribution pressure or increase in current or projected demand as well as international factors such as export. FDA will also weigh what shortage prevention or mitigation measures have been taken…