The new article addresses aspects related to submission issue requests as a specific type of submission under the Q-Submission program.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the requests for feedback and meetings for medical device submissions under the Q-Submission program. The said program is intended to streamline and facilitate the regulatory procedures associated with placing medical devices on the market. In particular, the program provides the possibility for a party interested in placing its product on the US market to request feedback from the authority before making the main submission. In such a way, the authority expects to be able to allocate its review resources in a more efficient way due to the overall improvement in the quality of submissions. 

At the same time, it is important to mention that the provisions of the guidance are non-binding in their legal nature, and are not intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance. 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 in advance. 

The document describes, inter alia, the way Q-Submission requests will be processed by the authority, and outlines important points associated with them. In particular, the authority explains the specifics of the review based on the Q-Sub type.

Submission Issue Request (SIR): Specifics

According to the guidance, apart from the general information to be included in all the requests, for this specific type, the authority expects the applicant (submitter) to provide the following:

  • Asking a specific question: a SIR should include clear, specific questions regarding review issues relevant to the planned response to the pending marketing submission holder letter (e.g., questions regarding non-clinical and clinical testing protocols or data needed to support the submission), IND Clinical Hold, or IDE letter, including identification of the deficiencies to be discussed, in order to focus FDA and submitter efforts on issues most relevant to moving a project forward. As further explained by the authority, should the submitter be interested in feedback with respect to the new data to be collected, the appropriate rationale should be provided for the approach suggested. At the same time, the authority additionally emphasizes that it will not design the study itself, but rather provide additional recommendations and highlight the key points to be considered by the responsible party. Furthermore, this type of request cannot be used for asking for the initial review of data, while it is possible to ask specific data-related questions, including those related to the way the data should be interpreted. 
  • Indication of a preferred feedback format. The submitter is also expected to indicate a specific format in which the feedback is requested (it could be either in writing, or during a meeting, but not both). Should the submitter decide to request a meeting with the authority, the latter will not provide its response in writing in addition to a meeting, while the submitter may take records of the meetings and respective minutes. 

SIR Review Process

The authority further describes in detail the way SIR should be reviewed. In this respect, the authority points out the following:

  • SIR should not be subject to acceptance review.
  • As it was mentioned before, feedback could be provided only in one of the forms. Furthermore, in line with the MDUFA Shared Outcome goals for Total Time to Decision, the authority intends to give priority in review to SIRs submitted within 60 days of the marking submission being placed on hold, an IND Clinical Hold, or an IDE letter. In such a way, the authority expects to ensure the most efficient use of its review resources, as there will be no need for additional review since the matter in question has just been reviewed by the authority. The said approach also places both the authority and the submitter in a situation where prompt resolution is favorable for both parties, ensuring the effectiveness of their cooperation. 

Hence, there are two possible ways for a SIR to be reviewed based on its type, namely:

  • Submission Issue Request A: If a Submission Issue Request is received within 60 days of the FDA’s marketing submission hold, IND Clinical Hold letter, or IDE letter, the FDA team will aim to provide feedback within 21 days, as resources permit.
  • Submission Issue Request B: If a Submission Issue Request is submitted more than 60 days after FDA’s letter, FDA will aim to provide feedback within 70 days, as resources permit. 

The above timeframes will be considered by the authority when providing its feedback to a SIR. Should the feedback be provided at a meeting, the applicant will be responsible for its minutes.

In summary, the present FDA guidance describes in detail the way submission issue reports will be reviewed by the authority. The document outlines the key points to be considered in this respect by the submitters and also provides an overview of the review process in general.

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