Update on Medical Products Shortage Reporting: What Manufacturers Need to Know Regarding FDA's New Reporting Guidance and Expanded Reporting Under the CARES Act
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On March 27, 2020, the US Food and Drug Administration issued a final guidance, entitled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act" (506C Guidance). The 506C Guidance describes, and provides recommendations for fulfilling, the requirement for applicable drug and biologic applicants and manufacturers to notify FDA of a permanent discontinuance in the manufacture of certain drug or biological products or an interruption in the manufacture of such products that is likely to lead to a meaningful disruption in supply of those products in the United States.
While the 506C Guidance addresses section 506C of the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations, which have collectively been in place since 2015, the ongoing Coronavirus Disease 2019 (COVID-19) pandemic prompted the release of this guidance. As a result of the COVID-19 pandemic, FDA has been closely monitoring the medical product supply chain and issued the 506C Guidance to assist applicable applicants and manufacturers in providing timely and informative notifications about changes in drug and biologic production to aid FDA in preventing or mitigating shortages of such products. On the same day FDA issued the 506C Guidance, the president signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) into law. The CARES Act expanded the scope and requirements under section 506C of the FDCA and amended the FDCA to include similar reporting obligations for medical devices. A decision tree that summarizes the notification requirements under section 506C as amended by the CARES Act has been included at the end of this Advisory.
© Arnold & Porter Kaye Scholer LLP 2020 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.