The new article addresses aspects related to the processes and procedures associated with the review of Q-Sub requests.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a revised guidance document dedicated to requests for feedback and meetings for medical device submissions under the Q-Submission program. The document describes in detail a special framework allowing parties interested in placing their products on the US market to request and receive feedback from the authority with respect to important submission-related matters before making the main submission. The authority expects this to improve the overall quality of submissions and also streamline and facilitate the procedures associated with placing new products on the market. At the same time, the guidance itself is non-binding in its legal nature and is not intended to introduce new rules or impose new obligations but rather to assist medical device manufacturers and other parties involved with complying with the applicable regulatory requirements by providing additional clarifications and recommendations to be considered. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed upon with the authority in advance. 

The scope of the guidance covers, inter alia, aspects related to the review process. In particular, the document describes the way the authority will review submissions under the Q-Sub framework and highlights the key points associated with it.

Review Process: Key Points

As described in the guidance, the submission review process is comprised of the following steps:

  1. Acceptance review. First of all, the authority conducts an acceptance review in order to assess the completeness of the submission and its compliance with the formal acceptance criteria. According to the guidance, this should be performed within 15 days from the day the review clock started. When conducting an acceptance review, the authority will use the Acceptance Checklist for submissions under the Q-Sub framework. Once the check is completed, the authority will notify the applicant accordingly by issuing the appropriate notification indicating whether the submission is accepted or not. As it is mentioned by the FDA, if a Pre-submission requesting a meeting is accepted, this notification will also either confirm the submitter’s requested meeting date or provide two alternative meeting dates that are scheduled before day 75. Should the request appear to be incomplete, an applicant will be notified about the refusal with the detailed explanations provided. In such a case, the applicant will be allowed to submit additional information. Once the latter is received, the authority will restart the review clock and conduct the acceptance review one more time using the same Acceptance Checklist. 
  2. Scheduling of meetings: As the next step, the authority will schedule a meeting with the applicant as requested, referring to the dates suggested by the applicant when possible. Should it be impossible for the authority to have a meeting on any of the dates suggested, it will offer at least two alternative options. According to the guidance, it is important to reach an agreement with respect to the dates within 30 days from the date the submission has been accepted. 
  3. Feedback. In case of feedback provided by the authority in writing, it will be shared with the applicant via email and will include detailed responses to the questions raised, as well as suggestions with respect to additional topics to be covered during the meeting. With respect to the applicable timeframes, the authority provides the following:
    1. Should no meeting be requested by the applicant, feedback will be provided in writing within 70 days from the date the complete submission has been received. This feedback will be deemed FDA’s official response to the request. 
    2. Should a meeting be requested, feedback will be provided in writing no later than 5 days in advance. It is important to mention that if the applicant finds a response provided by the authority satisfactory, subsequent meetings could even be canceled, while the written response will be considered the official one. However, if the meeting is conducted anyway, its minutes will be retained for official records. 

The authority additionally emphasizes that FDA should not be expected to review and respond to additional information prepared by the submitter and provided to FDA between receiving FDA written feedback and holding the meeting or during the meeting, as FDA does not have sufficient time to conduct a thorough review of this information; consequently, any information that necessitates additional FDA review should be submitted as a supplement to the Pre-Sub or in the eventual premarket submission. At the same time, the applicants (submitters) are encouraged to narrow the agenda in order to be able to focus on the most important matters.

General Considerations

According to the guidance, the feedback the authority will provide in response to a Q-Sub request will be based on the information provided by the applicant as well as all the information available to the authority at the time of the request. Under the general rule, the position of the authority expressed in feedback provided under the Q-Submission framework should not change in relation to the submission of a main application for premarket approval, unless there are significant changes to the underlying matters or the new information becoming available to the authority requires it to review its previous position due to the potential impact on matters related to the safety and/or effectiveness of medical devices. However, any changes to previously provided feedback would be limited to the extent necessary to reflect changes to the authority’s position. For instance, this could happen in the case of new scientific findings identifying a new risk or additional safety concerns. In such cases, the authority will duly document the rationale behind the changes and cooperate with the applicant. Moreover, due to rapid technological development, the authority recommends requesting confirmation of the validity of the feedback previously provided after 1 year to make sure the authority’s position remains the same. 

In summary, the present FDA guidance describes in detail the approach to be applied by the authority when reviewing requests under the Q-Submission program. The document outlines the most important aspects to be taken into consideration by the applicants with respect to specific review steps, the way the feedback could be provided, and the validity of the feedback in general.

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