Device shortage guidance gets a COVID update from FDA

Regulatory NewsRegulatory News | 02 December 2020 |  By 

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.
This information has particular relevance during the public health emergency: The agency notes that whether a device is assessed as being in shortage would, in turn, inform FDA’s ability to issue an emergency use authorization for a product. This is true because an EUA can only be offered when there are “no adequate, approved, and available alternatives.”
According to statute, information about shortages and discontinuations must be publicly available, though FDA has discretion not to make information available if disclosing it would have an adverse effect on public health – as when individuals hoard devices known to be in shortage.
FDA continues to prioritize review of submissions for authorization of devices that might mitigate or prevent shortages. “During the COVID-19 public health emergency, FDA intends to prioritize the types of inspections that can safely occur within a region,” according to the guidance. “When prioritizing such work, FDA considers 506J notifications as well as other information related to potential device shortages.” 


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