The new article addresses aspects related to some specific types of requests, and also provides a checklist to be used by the authority when assessing the requests for feedback.
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 requests for feedback and meetings for medical device submissions under the Q-Submission program. The said program allows medical device manufacturers to request and get feedback from the authority before filing a submission. In such a way, the authority expects to be able to ensure a better allocation of its review resources due to the overall improvement in the quality of submissions.
It is important to mention that the FDA guidance documents 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 and recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance with the regulatory requirements set forth under the existing framework. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the current legislation and has been agreed upon with the authority in advance.
The scope of the guidance covers, inter alia, the process of Q-Submission review based on the submission type. In particular, the document describes the approach to be applied by the authority when reviewing different submission types and highlights the key points to be considered by the applicants (submitters) in this respect.
Study Risk Determination Requests
With respect to the content of study risk determination requests, the authority expects the applicants to provide a protocol for the proposed clinical study in addition to the general information usually covered by Q-Subs.
As further explained by the FDA, study risk determination requests are not subject to the acceptance review carried out on other types of requests in order to assess whether they are complete and meet the applicable requirements. Instead, the authority will proceed with a substantial review, upon completion of which it will provide the applicant with a letter stating whether the study in question is subject to exemption or, if not, whether it falls within a Significant Risk (SR) or Not Significant Risk (NSR) determination. A copy of this letter, together with the suggested study protocol, could be later shared with the IRB – in such a case, the latter will rely on the FDA’s determination instead of conducting its own independent risk assessment.
In the case of informational meetings, there are no specific requirements to be followed in terms of the submission content, apart from the general information to be included in the cover letter for all submission types. Thus, when determining the scope of information to be included, the applicant should decide what will be reasonable based on the most important matters to be addressed.
As in the previous case, for this type of request, acceptance review is not required.
The authority’s feedback will be provided in the course of a meeting to be conducted within 90 days from the date the request was received, based on the availability of resources.
Other Submission Types
Apart from the ones described herein above, the authority also outlines other types of submissions allowed under the Q-Submission framework, as well as other possible uses of the Q-Submission program in general. According to the guidance, they include:
- PMA Day 100 Meetings;
- Agreement and Determination Meetings;
- Breakthrough Device submissions;
- Accessory Classification Requests;
- STeP submissions;
- Requests for recognition of publicly accessible genetic variant databases; and
The authority is going to provide further information and guidelines in order to ensure the information about requirements and applicable timelines for each of the submission types is duly communicated to the interested parties.
Pre-Submission Acceptance Checklist
In order to assist the applicants in submitting their requests under the framework described herein, the authority also provides an example of a checklist to be used in order to ensure the completeness of the submission and its eligibility for review. The checklist includes the following questions:
- Has the submitter provided a specific purpose or goal for their Pre-Sub?
- Has the submitter described the device(s) or other product(s) to be discussed in their Pre-Sub?
- Has the submitter provided specific questions that request FDA feedback?
- Does the submission indicate that the submitter intends to submit a future IDE, CLIA Waiver by Application, IND, or marketing submission related to the feedback being requested?
- Do the provided questions pertain to a file under active review?
- Do the provided questions relate to a marketing submission or CLIA hold letter, an IND Clinical Hold letter, or an IDE letter?
The authority further explains that answers “No” provided to questions 1-4 would most probably result in the submission being rejected or converted to a specific submission type, while answers “Yes” to the same question are required to proceed further. At the same time, the desirable answer to questions 5-6 is “No”, otherwise a change of submission approach will be required.
The authority additionally emphasizes the importance of ensuring the submission contains clear and specific questions related to the planned submissions, as it is important for the authority to focus on the most important matters. Based on previous experience with this pathway, the authority confirms that a focus on a few key topics is the most productive approach.
In summary, the present FDA guidance provides additional clarifications and recommendations regarding the content of submissions under the Q-Submission program that applicants should take into consideration in order to ensure the effectiveness of the procedures. The document outlines the most important aspects and explains the approach the authority will apply.
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