The Center for Devices and Radiological Health (CDRH), the unit of the Food and Drug Administration (FDA or the Agency) responsible for medical devices regulation, issued guidance document describing the way medical device manufacturers should notify CDRH of a permanent discontinuance of interruption in manufacturing medical devices in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus” and the public health emergency announced earlier in February in connection to the pandemic. It is important to mention that due to the national health emergency announced in March 2020 and the outbreak of the aforementioned disease, the present guidance should be subject to immediate implementation, without carrying out public consultations usually taken to collect the feedback from the industry representatives since the regulatory aspects it covers are vitally important for the protection of public health. At the same time, comments still could be submitted in accordance with the general procedure. The measures implemented by the guidance would remain effective only during the public health emergency related to the COVID-19 outbreak.
FDA COVID-19 Regulatory Background
The present FDA CDRH guidance is based on section 506J of the Federal Food, Drug, and Cosmetics Act (FD&C Act), the primary law regulating operations with medical devices placed on the US market and allowed to be used within the US in healthcare facilities or by directly by the patients. The guidance is intended to implement the extraordinary measures necessary to mitigate the risk associated with the potential shortages in supply of the vitally important medical devices during the pandemic. According to the section 506J, the medical device manufacturer is obliged to duly notify the regulating authority about its intent to suspend the production of certain medical devices or any interruptions occurred to their production in case if this could result in shortages in supply of the device in question on the US market. The guidance describes the way the manufacturers should provide the FDA with the information on such changes to the production providing that the Agency would be able to implement the measures reasonably necessary to reduce the risk of potential shortages in supply of the vitally important medical devices during the COVID-19 outbreak. The document also describes the information to be provided by the manufacturer in the context of the changes to the production covered by the scope of the guidance.
It is important to mention that the aforementioned provision 506 of the FD&C Act has been amended earlier in March 2020, to address the issues related to the pandemic. In particular, the new section 506J has been added, providing the Agency with the additional powers related to the implementation of the additional measures reasonably necessary to prevent the potential shortages. According to these amendments, the medical device manufacturers shall notify the Agency “of a permanent discontinuance in the manufacture of the device or an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in supply of that device in the United States”, while the present CDRH guidance describes in details the way the manufacturer shall submit such notification, as well as the information to accompany it.
CDRH Notification Rules
According to the aforementioned regulation, the manufacturer shall duly notify the Agency of an interruption or permanent discontinuance in manufacturing of the medical device that is:
- Vitally important during the pandemic (e.g. life-supporting, life-sustaining or emergency medical care devices); or
- One the authority requires to inform on potential shortages due to the importance of the device during the pandemic.
Thus, the scope of the guidance covers the medical devices that are most important during the COVID-19 outbreak, including such FDA-cleared medical devices as ventilators, thermometers, or surgical gowns. At the same time, the manufacturers that have not received the appropriate FDA approval (providing that the device in question has been placed on the market on the basis of the enforcement discretion) are actually exempted from the aforementioned requirements.
According to the applicable regulations, medical device manufacturers should notify the authority of any potential disruptions in case if the device in question is critically important during the COVID-19 outbreak. To assess whether this requirement should be applied, the Agency recommends to consider whether the device is intended to:
- diagnose or treat the coronavirus disease (e.g. PCR tests),
- be used during the surgery,
- be used for emergency medical care, or is a life-supporting or life-sustaining device, or whether it faces a significant increase in demand due to the pandemic.
It is also advised to consult with the Agency in case of any doubts regarding the applicability of the notification rules described herein to the particular medical device.
CDRH Notification Procedure and Additional Requirements
According to the section 506J(b), the medical device manufacturer shall duly notify the regulating authority about the planned permanent discontinuance in production of the device or any interruptions to the production process that potentially could result in shortages in supply of the device at least six months before such actions would take place. However, if due to existing circumstances it is not reasonably possible, the manufacturer shall notify the Agency “as soon as is practicable”, that for the purpose of the present CRDH guidance means that the appropriate notification should be submitted at least 7 calendar days starting from the date such event took place. In this case, the authority will actively cooperate with the manufacturer of the device and other industry representatives in order to prevent the impact that could be potentially caused to the public health by the possible shortages.
The document also provides the definition of the term “meaningful disruption” that is widely used to describe the situation the authority should be informed about. In particular, the meaningful disruption is defined as “a change in production that is reasonably likely to lead to a reduction in supply of a device by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product.” The Agency also explicitly states that when considering the necessity of notifying the authority, the manufacturer should make a decision based solely on its own capacity and supply irrespectively of the actions taken by other medical device manufacturers or current situation on the medical devices market.
Summarizing the information provided hereabove, the present CDRH guidance is intended to provide medical device manufacturers producing the device that are vitally important during the pandemic with the detailed guidelines describing the way the authority should be notified of any potential disruptions of supply that could potentially result in shortages in supply of the certain medical devices.
It is important to mention that the Agency implements a wide scope of extraordinary measures intended to ensure and expand the availability of the vitally important medical devices on the US market during the pandemic. This includes the Emergency Use Authorization (EUA) framework allowing medical device manufacturers to reduce the time needed to make the device available for the patients and healthcare professionals, and also other additional policies covering various aspects related to using and marketing critical supply medical devices on the market.
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