The new article provides additional information about the submission process depending on the submission type.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published an updated guidance document dedicated to requests for feedback and meetings for medical device submissions under the Q-Submission program. The said program is intended to facilitate and streamline the regulatory procedures associated with placing new products on the market by providing the applicants with the possibility to request and get feedback from the authority regarding important matters before filing the main submission. As explained by the authority, this approach helps the FDA better utilize its review resources and also contributes to the overall improvement of the submissions’ quality in general. The document provides an overview of the applicable regulatory requirements as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance. 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. 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 discussed with the authority in advance.
In particular, the document explains in detail the submission process based on the submission type since it could differ in terms of timeframes and the information the authority expects to be provided for review.
Review Process: Summary
First of all, the document provides a summary table highlighting the key points associated with the review process for the main submission types. In particular, the authority states the following:
- For a Pre-Submission, feedback could be provided either only in writing or as written feedback followed by the meeting. The applicable timeframe is 70 days for written feedback and then 5 days after that for a meeting (if applicable).
- For a Submission Issue Request (SIR), feedback could be provided either in writing or at a meeting. The timeframe will be 21 days if received within 60 days of the marketing submission letter and 70 days if received later.
- For a Study Risk Determination, feedback will be provided as a formal letter with an applicable timeframe of 90 days.
- An Information Meeting provides a memo as the only format of feedback, and the applicable timeframe is 90 days.
The document further describes in detail each of the abovementioned submission types and outlines the most important aspects associated with them.
Pre-Submission
According to the guidance, the content of a Pre-Submission should cover, inter alia, the following aspects:
- Planned Follow-On Submission. The applicant is expected to provide details on the type of submission to be filed so that the authority will be able to provide more specific feedback.
- Background Information. The authority also expects the applicant to provide sufficient information regarding the matter that it will reasonably need to assess the request and be able to provide substantial feedback. As further explained by the authority, this information might include literature articles, a full device description with engineering drawings, proposed labeling, videos, and/or red-lined protocol revisions, depending on the specific questions for which the feedback is requested. Apart from that, the applicants are encouraged to provide references to the relevant guidance documents and regulations, together with explanations on how the respective aspects will be addressed. At the same time, the authority also mentions that the scope of the information provided should be reasonable, as the submission of extraneous information can be counterproductive. Thus, the applicants are encouraged to make sure the information provided is comprehensive and reasonably necessary for the authority to assess the case and provide feedback. Should it be reasonably needed to provide additional background information, the part of it directly related to the matter should be clearly indicated.
- Specific questions. According to the guidance, the submission should contain specific questions the applicant needs clarification on in order for the authority to be able to focus on the most important aspects. Moreover, the applicants are encouraged to describe their position on the matter. As it was mentioned before, the authority expects the applicant to pay special attention to the number of topics raised so that the authority will have sufficient time to investigate each of them and provide substantial feedback. Under the general rule, the number of topics brought up for discussion should not exceed 3–4. However, the submission could also include additional questions, provided they are straightforward and do not require an in-depth review in order to be answered. Should the authority find the number of topics covered by the submission to be excessive, it will reach out to the applicant to discuss the priorities. Sometimes it will be reasonable to discuss matters of lower priority as part of subsequent submissions.
Additional Aspects
The guidance also provides additional clarifications regarding some of the common questions included in Pre-Subs the authority receives from the industry.
- Study Protocols. Under the general rule, the authority cannot prepare or design study plans; however, the authority can provide feedback with respect to the draft suggested by the applicant. The latter is also encouraged to include specific questions to make the discussion more productive.
- Data Review. The authority will not conduct the data review in the course of the Pre-submission review process. At the same time, the authority can answer specific questions related to the interpretation of data and the need for additional research.
- Regulatory Approach. The program described herein allows the authority to provide feedback with respect to the applicable regulatory approach.
In summary, the present FDA guidance outlines the key points to be considered by interested parties when preparing and filing submissions under the Q-Submission program. The document provides recommendations to be followed in order to streamline and facilitate the procprocess,uring the effectiveness of communication in general.
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