The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices, issued guidance dedicated to formal meetings and user fee applications for 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”.
FDA’s Regulatory Background
The outbreak of COVID-19, which was announced in March 2020, required the FDA to implement additional temporary and extraordinary measures necessary to maintain normal operations of the Agency to ensure the uninterrupted availability of medical devices on the US market. Due to the respiratory illnesses and complications caused by the virus, some of the medical devices become vitally important. This particular FDA guidance is intended to provide medical device manufacturers with additional clarifications regarding the applicable rules and requirements related to medical device development during the pandemic. It is also important to mention that the document will remain effective only during the public health emergency associated with the COVID-19 outbreak, announced by the Secretary of Health and Human Services (HHS). Another important point is related to the implementation procedure: the guidance is intended to be implemented immediately without prior public consultations with industry representatives as required under the general rules. The FDA applied this procedure in order to avoid any delays in the implementation of the provisions set forth in the present guidance due to its importance under existing conditions. The document does not set forth any additional responsibilities or mandatory rules that medical device manufacturers must follow. Instead, the FDA guidance provides necessary recommendations to be considered in order to maintain compliance with the applicable requirements. The Agency also states that special regulatory measures implemented in the context of the public health emergency associated with the COVID-19 outbreak could be amended if the situation changes significantly.
Formal Meetings with Medical Device Manufacturers
The Agency’s guidance describes the approach that is to be used when scheduling meetings with medical device manufacturers regarding their submissions or review of the applications that have been already filed before the COVID-19 outbreak took place. In particular, the Agency intends to implement the following measures:
- The FDA intends to expand the use of information and telecommunication technologies in order to temporarily replace face-to-face meetings with teleconferences and videoconferences. Such measures would be implemented to protect the health of both FDA personnel and representatives of medical device manufacturers. Thus, all upcoming meetings will take place as teleconferences, while the particular date and time will remain unchanged. It is important to mention that the CDRH intends to use only teleconferences, while the CBER is free to choose between teleconferences or videoconferences. The representatives of the aforementioned regulating authorities have already commenced contacting industry representatives to inform them about changes to the meeting format. The FDA also encourages medical device manufacturers that have a scheduled meeting in place but still haven’t received the appropriate announcement, to contact the regulating authority regarding this matter.
- The Agency is going to continue accepting new Q-submission requests. Depending on the indication included in the request, the authority could either schedule a meeting or provide a written response.
- The Agency is still considering carrying out advisory committee meetings in a remote format. In particular, the authority states that such meetings could be performed remotely using available ICT. The authorities would contact the applicants directly to discuss the possibility to switch to remote communications. The Agency also states that meetings about regulatory issues could also be carried out online.
The Medical Device User Fee Amendments in the Context of COVID-19
The present FDA guidance also describes the way the outbreak of the Coronavirus Disease 2019 would impact submissions related to the Medical Device User Fee Amendments (MDUFA). Regarding this matter, the Agency states the following:
- The number of requests related to the pre-Emergency Use Authorizations, as well as EUAs, has increased significantly during the pandemic. The Emergency Use Authorization is a special regulatory framework intended to allow placing vitally important medical devices on the US market and making them available to patients and healthcare professionals before the approval issued by the FDA. This framework allows medical device manufacturers to accelerate all procedures related to placing a new medical device on the market and temporarily reduces the regulatory burden. This allows the FDA to engage more specialists in procedures related to medical devices that are most important in the context of the COVID-19 outbreak, while it becomes difficult to maintain the same efficiency level when reviewing other submissions.
- The FDA is going to take all reasonable measures to achieve MDUFA performance goals within the initially determined terms. At the same time, due to the impact of the aforementioned COVID-related factors, the authority could face certain difficulties that could result in delays. The FDA is not intended to extend the initial timeline at the moment. However, if it would be reasonably necessary, the Agency would properly inform all related parties.
- Special rules should also be applied regarding marketing submissions or applications on hold. In particular, the Agency reserves the right to deem the application or submission as withdrawn by the applicant if the appropriate response would is not provided in time. In particular, the following timelines should be applied: 180 days for additional information related to 510(k) and De Novo submissions, and 360 days for Humanitarian Device Exemption (HDE) applications. At the same time, the Agency acknowledges that medical device manufacturers could face some delays due to the impact of COVID-related factors. If so, they should apply for the extension, while the FDA itself could be unable to process the increasing number of applications for an extension. For such cases, the authority will provide an additional 90 days before the application would be determined as withdrawn. It is important to mention that the aforementioned rule could be applied even if the applicant hasn’t submitted the appropriate extension request. However, in accordance with the FDA guidance, the medical device manufacturer (the applicant) shall duly inform the regulating authority about any actual or potential delays as soon as it is reasonably possible.
- It is also recommended to contact the regulating authority if the medicinal product in question falls under the scope of the Biologics License Application to inform about any delays in goal dates. If such a medical device should be subject to regulation by CBER, the aforementioned authority should contact the applicant directly.
Summarizing the information provided hereabove, the FDA guidance describes special measures implemented by the Agency in order to ensure the availability of vitally important medical devices during the pandemic.
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