FDA COVID-19 Regulatory Background
The present 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 measures necessary to mitigate the risk associated with the potential shortages in the supply of vitally important medical devices during the pandemic. According to the section 506J, the manufacturer is obliged to duly notify the regulating authority about its intent to suspend the production of certain medical devices or of any interruptions that occurred during production that could result in shortages in the supply of the device in question. The guidance describes how manufacturers should provide the FDA with information on such changes, providing that the Agency would be able to implement the measures reasonably necessary to reduce the risk of potential shortages in the supply of 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 the supply of that device in the United States.”
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 section 506J(b), the manufacturer shall duly notify the regulating authority about permanent discontinuance in the production of a device or any interruptions to the production process that potentially could result in shortages in the 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.” The appropriate notification should be submitted at least 7 calendar days starting from the date such an 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 the 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.
Summarizing the information provided here above, the present CDRH guidance is intended to provide medical device manufacturers producing with detailed guidelines on how the authority should be notified of any potential disruptions of supply that could potentially result in shortages in the 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.
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. Comments may still 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.
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