The new article describes in detail the procedure to be followed when submitting a request under the Q-Submission framework. In particular, the authority pays attention to the content of submissions.
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 allows medical device manufacturers to obtain feedback from the authority before submitting the main application for marking approval. The FDA expects this will be beneficial for the overall improvement of the submissions’ quality, and also contribute to better allocation of review resources of the authority.
It is important to mention that FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the existing regulatory framework, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the underlying legislation and has been agreed with the authority in advance. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the applicable regulations.
In particular, the document describes in detail the process to be followed when submitting a request under the Q-Submission program. The authority provides additional clarifications regarding the content of submissions and applicable timeframes.
Submission Content: Cover Letter
First of all, the authority emphasizes the importance of ensuring the accuracy and completeness of requests. According to the guidance, a cover letter accompanying the Q-Submission request should contain the following elements:
- Contact Information, including the name, address, and contact person representing the applicant (submitter).
- Q-Submission Type (the authority explicitly states that only one type could be included in each submission).
- Method of Feedback. Should the submission type provide the possibility to choose the method to be used to provide feedback, the appropriate reference should be included in the request. For instance, the authority can provide its feedback in writing only, or in a meeting (both options could apply simultaneously as well). Thus, it is important to ensure that the feedback method requested is clearly indicated in the submission.
- Meeting information. In case the submission type used provides an option for a meeting, and it is requested by the submitter, additional details are to be included, namely:
- A draft agenda proposing the topics to be presented and the estimated time for each agenda item, to the extent possible pending FDA feedback;
- The meeting format requested;
- Three or more preferred dates and times when the submitter is available to meet (considering the time the authority would reasonably need to review the request and discuss it internally);
- The planned attendees, including each attendee’s position, title, and affiliation (the submitter may also request specific FDA staff to be present in case of specific expertise needed).
Submission Content: Key Elements
Apart from the above, in order to ensure that the response provided by the authority will be meaningful and useful for the applicant, the body of the submission itself should provide the following details:
- Purpose of the submission, its goals, and desired outcome.
- Device or Product Description, i.e., an explanation of how the device functions, the basic scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device. The authority also expects the submitter to provide information about the manufacturing process in the context of the way it could impact the safety or proper performance of the device, s o this should be considered by the authority when providing its feedback. Such information should be accompanied with images and other visual materials the submitter finds appropriate to illustrate the information provided. According to the guidance, it is vitally important for the authority to understand the key components of the device to be discussed, as well as the technologies used.
- Proposed Indications for Use or Intended Use. The submitter is also expected to include a detailed description of specific diseases and conditions for which the device is intended to be used, as well as the patient population. This information is also important for the authority to be able to provide accurate feedback.
- Regulatory History. The submission should also provide details about any communications with the authority regarding the subject matter, including any previous submissions or feedback received.
As further explained by the FDA, an eCopy of the submission should be filed in accordance with the respective regulatory requirements. In this regard, the authority refers to the appropriate guidance document.
The guidance also provides additional clarifications regarding the submission flow depending on the review center to be responsible for the product in question, as well as recommendations to be followed in order to facilitate the process.
According to the guidance, the FDA review clock will start from the moment a valid eCopy has been received by the authority. At the same time, if the submission requires an acceptance review to be conducted by the authority before reviewing the matter itself, the usual approach applies – should the authority reasonably require additional information to complete the review, the submitter will be notified accordingly, and the review process will be placed on hold to be resumed once additional information is provided.
In summary, the present FDA guidance provides an overview of the content requirements for the requests under the Q-Submission program. The document outlines the key elements thereof and also provides additional recommendations to be considered to facilitate and streamline the review process.
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