The U.S. Food and Drug Administration (FDA) released a new guidance document on January 11, 2022 titled “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C Act.” This new guidance discusses how medical device manufacturers should report supply chain issues during a public health emergency (PHE). FDA had released an earlier guidance during the COVID-19 pandemic, and this guidance required medical device manufacturers and distributors to notify FDA of product shortages for as long as the PHE continued. The intent was to manage or combat the major supply chain issues that occurred during the PHE. This second guidance takes things one step further by asking companies to report on supply chain challenges, which could contribute to shortages.
This new guidance sets forth the notice requirements, including the timeline by which device and diagnostics makers must notify FDA of supply chain problems. Notice is provided through FDA’s website. The guidance also notes that if a manufacturer fails to notify FDA without a good reason, the agency will name the company on its website for noncompliance. The guidance discusses: the parties responsible for notifying FDA, what information should be provided to FDA, and how it should be communicated. It is important to note that, according to the guidance, FDA may conduct inspections, expedite product reviews, and take additional precautions as necessary during or approaching a product shortage. These precautions will enable FDA to act in advance and prioritize approvals of certain products that may ameliorate the shortage during an emerging PHE.
Product shortages have had such a detrimental impact on public health during the COVID-19 pandemic that FDA is trying to take a collaborative approach to prevent the catastrophic shortage of personal protective equipment (PPE), ventilators, and other relevant medical devices and products from reoccurring. During the comment period for the new guidance, it is likely that some parties may express a desire to extend the guidance beyond PHEs to become an everyday requirement. Interested parties may submit comments on this guidance until March 12, 2022 under docket number FDA-2022-D-0053 on Regulations.gov.
This guidance document will likely be relevant to the manufactures of devices that are life-supporting or life-sustaining as well as products and components that were used to create diagnostic devices during the pandemic. FDA created a source of information that identifies those devices most likely to require notifications in case of shortage. Manufacturers should review this list to determine if their products are identified among those products highlighted by FDA to prepare for compliance activities during future PHEs.