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FDA Issues Guidance Related to CARES Act Amendments for Medical Device Manufacturers

May 13, 2020

The U.S. Food and Drug Administration (FDA) recently published new guidance (the Guidance) related to actual or potential medical device shortages during the COVID-19 pandemic The Guidance is meant to implement Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351 et seq.), which was added under Section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

Section 506J provides new reporting obligations and a framework to be used during public health emergencies for certain device manufacturers. The Guidance is meant to "clarify and make recommendations" about the scope of this amendment. The Guidance specifically applies only to devices regulated by the Center for Devices and Radiological Health (CDRH) during the COVID-19 pandemic.

Section 506J of the FD&C Act requires device manufacturers to notify the FDA of any permanent manufacturing discontinuance or interruption that is likely to lead to a disruption in the supply of certain devices in the United States. The policy behind this notification requirement is to enable the FDA to manage or prevent device shortages during public health crises. This is not meant to apply to negligible disruptions such as those caused by routine maintenance or interruptions in materials that will not lead to a shortage of the device.

506J applies to manufacturers of devices that are critical to public health during a public health crisis or manufacturers of devices for which, as determined by the Secretary of the FDA, information is needed during or in advance of a public health emergency. Such manufacturers include, for example, those manufacturing life-supporting or life-sustaining devices, or devices intended for emergency medical care. However, many other device manufacturers may be governed by 506J.

The required notice is to be made at least six months prior to the date of disruption or as soon as possible. It is important to note that, subject to certain exceptions, the FDA will add the device to a publicly available device shortage list. In addition, the reported information may be made available to appropriate organizations, including physicians, health providers, patient organizations and supply chain partners, as the FDA deems appropriate. Certain information such as trade secrets and confidential information may be kept confidential. The information necessary in the notification should include the reasons for the discontinuance or interruption, the impact this may have on responses to the COVID-19 pandemic and other identifying information.

Also, under 506J, a new device shortage list will be maintained by the FDA, containing the device name and the manufacturer's name, the reason for the shortage as determined by the FDA, and the estimated duration of the shortage.

The Guidance is intended to assist device manufacturers in providing the FDA with the production information the FD&C Act requires. The Guidance also recommends that manufacturers voluntarily provide additional details to assist the FDA in the implementation of this policy. The Guidance provides an email address for manufacturers to submit notifications and an email address for any questions about the Guidance, as well as an example of an appropriate notification.

Attorney Advertising. The information contained in this Legal Alert provides a general summary of the topics covered and is not intended to be and should not be relied upon as legal advice. You should consult with your legal counsel for advice and before making legal, business or other decisions.

 

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