The Food and Drug Administration (FDA or the Agency) issued detailed guidelines dedicated to adverse event reporting rules for medical devices placed on the market under the Emergency Use Authorization (EUA). The EUA is a special regulatory framework implemented by the Agency to avoid potential shortages and ensure the availability of vitally important 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”.
Emergency Use Authorization Concept
The Emergency Use Authorization is a special regulatory framework intended to be applied in case of an emergency or adverse event. Therefore, it can only be applied if special circumstances are present. The EUA procedure could be applied in case of:
- A domestic emergency, or if there is significant potential for a domestic emergency,
- A military emergency, or if there is significant potential for a military emergency,
- A public health emergency, or if there is significant potential for a public health emergency,
- A material threat that could affect national security.
The appropriate determination should be made via a EUA declaration made by the HHS Secretary. If the underlying conditions are no longer present, the EUA declaration will be terminated, which will lead to the termination of all EUAs granted on the basis of the initial EUA declaration.
In accordance with the appropriate FDA guidance, the EUA can be issued only if the medical device in question meets pre-defined eligibility criteria, namely:
- The medical device is intended to treat a serious or life-threatening disease or condition,
- The medical device shall fall within the scope of the “may be effective” concept. This requires a lower level of evidence to be provided by the medical device manufacturer rather than the general “effectiveness” standard.
- The potential benefit from using the medical device shall exceed the identified and potential risk associated with the use of the device for its intended purpose indicated by the medical device manufacturer. Such determination should be made on the basis of the scientific evidence available, including data from clinical trials.
- There should be no FDA-approved alternatives to the medical device subject to EUA.
The FDA states that information to be provided by the medical device manufacturer when applying for the Emergency Use Authorization may vary, but in general, it should cover the following:
- A description of the product and its intended purpose, including information about the conditions the device is intended to be used in or life-threatening diseases the device is intended to treat, prevent, diagnose, or mitigate.
- Information about the FDA approval status.
- A justification of the existing need for the medical device in question.
- Information on the safety and effectiveness of the device when used as intended by the manufacturer.
- Information about benefits and risks.
- Details about the manufacturing process and procedures, including the information about controls applied at the manufacturing sites.
- Information about the number of medical devices already available, as well as details on the capabilities of the manufacturing sites.
- Details on the instructions for use.
- A justification of the shelf life period extension (if applicable).
Information related to safety that the medical device manufacturer shall provide in the course of applying for the EUA actually depends on the device subject to review and numerous factors associated thereto. If the clinical data is already available, it should be provided with the application. If the medical device manufacturer is unable to provide such data, the information on bench testing could be provided instead.
As it is indicated in the FDA guidance, the Emergency Use Authorization could be applied for allowing the unapproved use of approved products, or the use of unapproved products in general.
Adverse Event Reporting Requirements Under EUA
The present FDA guidance is intended to provide manufacturers with important information related to reporting requirements applicable for medical devices placed on the market under the Emergency Use Authorization framework. The Agency states that numerous EUAs have been issued to expand the availability of medical devices facing a significant increase in demand during the pandemic.
According to the guidance, the particular adverse event (incident) reporting requirements the medical device manufacturer shall follow are specified in the Conditions of Authorization indicated in the EUA. Under the general rule, the manufacturer shall act in accordance with the requirements set forth in 21 CFR Part 803 providing that medical device manufacturers submit Medical Device Reports (MDRs).
MDR Submission Procedure
As it is stated in the FDA guidance, the MDR should be submitted through the electronic form. When describing the submission process, the Agency refers to the appropriate Q&A document dedicated to the Electronic Medical Device Reporting (eMDR). According to the aforementioned document, the MDR should be submitted via the special system using a dedicated account providing access to the Electronic Submission Gateway.
The Medical Device Report should also contain the appropriate product code assigned to the medical device in question. This will help the FDA reduce the time needed to review the documents and accelerate the whole process. As it is stated in the guidance, if the correct product code is indicated in the MDR, the Agency will have fewer additional requests. When determining which particular product code should be indicated in the Medical Device Report, the medical device manufacturer shall refer to the FDA`s product classification database. For example, the following product codes could be applied to medical devices placed on the US market under the EUA:
- Face masks for general use – QKR
- Face shields – LYU
- Protective barrier enclosure – QLD
- Protective barrier enclosure with negative pressure – QLE
- Surgical respirators – MSH
MDR Reporting Timeframes and Additional Rules
According to the guidance, the medical device manufacturer shall submit the appropriate MDR within either 5 or 30 days from the particular day it becomes aware of the incident that took place. The Agency additionally emphasizes that the calculation of reporting timeframes will commence from the day the medical device manufacturer becomes aware of the incident, and not from the date the event itself occurred.
It is also important to mention that the special reporting rules implemented by the FDA for the period of the pandemic are not applicable for medical devices allowed to be marketed in the US under the Emergency Use Authorization. According to the FDA guidance, any and all medical devices placed on the market under the EUA framework should be subject to reporting requirements in accordance with the 21 CFR Part 803.
Summarizing the information provided hereabove, the present FDA guidance on reporting requirements for medical devices placed on the US market under the Emergency Use Authorization provides medical device manufacturers with additional recommendations intended to assist them in maintaining compliance with the applicable reporting requirements.
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