The Food and Drug Administration (FDA) has published guidance dedicated to the medical device submissions under the Q-Submission program. The document describes the regulatory requirements introduced under the appropriate framework and also provides medical device manufacturers and other parties involved with additional clarifications and recommendations to be considered to achieve and sustain compliance thereto. The initial version of the guidance has been published by the FDA earlier in May 2019. It is also important to mention that due to its legal nature the FDA guidance does not implement regulatory requirements itself, but describes the approach to be applied. At the same time, the Agency states that an alternative approach could be also applied, providing that such an approach complies with the regulatory requirements and was agreed with the regulating authority in advance.
Regulatory Background
The present FDA guidance describes the procedures to be followed by the medical device manufacturers requesting feedback from the regulating authority with regard to the following types of applications:
- Investigational Device Exemption (IDE) applications,
- Premarket Approval (PMA) applications,
- Humanitarian Device Exemption (HDE) applications,
- Evaluation of Automatic Class III Designations (De Novo requests),
- Premarket Notification (510(k)) Submissions,
- Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW),
- Dual 510(k) and CLIA Waiver by Application Submissions (Duals),
- Accessory Classification Requests, as well as certain
- Investigational New Drug Applications (INDs), and
- Biologics License Applications (BLAs).
The scope of the document also covers the cases when the applicant requests a meeting with the FDA representatives, either face-to-face or with the use of telecommunication means.
According to the document, the consultations conducted with the FDA prior to submission of the application were initially introduced earlier in 1995. For the first time, such procedures were applicable only in the context of the IDE applications, but later their scope was extended to include other types of applications as well.
The Q-Submission program addressed herein has been introduced later in 2014, while in 2017 it was modified and improved by the Medical Device User Fee Amendments of 2017 (MDUFA IV).
The interactions with the regulating authority falling within the scope of the present guidance include the following ones:
- Pre-Submissions (Pre-Subs), which actually constitute a formal written request from a submitter for feedback from FDA that is provided in the form of a formal written response or, if the submitter chooses, formal written feedback followed by a meeting in which any additional feedback or clarifications are documented in meeting minutes. This approach allows the interested party to obtain FDA`s feedback with regard to its planned application before its actual submission. In order to make it more efficient and fruitful, the interested party shall outline the questions it is mostly interested in. On the basis of such a request, the regulating authority would provide feedback on the matters in question to assist the interested party in product development or preparation of a submission. The Agency additionally emphasizes that participation in the Q-Submission program is voluntary and remains at the sole discretion of the interested party. At the same time, additional consultations with the regulating authority could be useful in terms of overall improvement of the quality of the submission, and also reduce the time necessary for the FDA to review the submission. This could be also useful to reduce the probability of refusal. The Agency recommends requesting the feedback as described hereinbefore commencing the planned testing of a medical device in question. However, it is important to mention that under the current legislation, the interested party requesting feedback from the FDA is not obliged to fix the issues identified and indicated by the authority. Hence, the feedback provided by the Agency in the course of participation in the Q-Submission program should not be treated as a mandatory prescription to be followed. In case of an Accessory Classification Request, an additional meeting with the representatives of the regulating authority would be required.
- Submission Issue Requests (SIRs). This type of request should be used in case if the applicant is seeking assistance in addressing the issues identified in marketing submission. For instance, this could be applied in case of additional information needed for the submissions highlighted hereinabove. This approach is intended to make communications between the applicant and regulating authority more efficient in order to solve the issues within the shortest period of time. At the same time, the Agency emphasizes that SIR submission does not impact the general response timeframe within which the applicant shall provide its response to the FDA`s request related to the submission filed. Moreover, SIRs also could not be applied in case of final decisions taken by the FDA.
- Study Risk Determinations. This type of request should be applied when the applicant requests the FDA to determine the risk of a planned medical device clinical study. According to the current risk-based classification, such a study could be determined as “significant risk (SR)”, “non-significant risk (NSR)”, or even exempt from IDE regulations. Under the general rule, the interested parties themselves are responsible for the initial risk determination. At the same time, upon the appropriate request, the Agency could assist the applicant in making a correct determination. In any case, the determination made by the FDA should be final.
- Informational Meetings. Such meetings could be initiated by the medical device manufacturer interested in sharing with the Agency the information about the ongoing development process, or in order to familiarise the representatives of the regulating authority with entirely new medical devices based on the novel technologies and solutions. In the course of such meetings, the Agency’s representatives are allowed to ask the manufacturer to provide additional information on the matter. At the same time, any feedback would not be provided as the result of such a meeting.
- Other Q-Submission Types. Besides the ones listed hereinabove, other types of Q-Submissions could also take place. By the virtue of such requests, the interested parties intended to place their medical devices on the US market could ask for feedback with regard to certain device-specific aspects to be clarified in advance – before the submission would be filed. This includes, inter alia, the Breakthrough Device Designation Requests, Agreement, and Determination Meetings, PMA Day 100 Meetings, as well as the submissions associated with the Safety Technologies Program (“STeP”).
Additional Aspects
The document also describes certain additional aspects to be considered by the parties seeking the FDA feedback. For instance, the guidance states that in certain cases, the appropriate feedback could be provided by the Agency even in the context of the Information Meetings, despite such type of meetings does not initially prescribe this.
Summarizing the information provided here above, the present FDA guidance on the Q-Submission program describes the approaches to be applied by the medical device manufacturers or other parties interested in obtaining feedback from the Agency with regard to its planned submission. The document outlines existing types of requests and highlights their core features.
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