The new article describes in detail the approach to be applied with respect to meetings under the Q-Submission program and also clarifies the way unique numbers are assigned to incoming requests in order to ensure traceability.
Table of Contents
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 framework described in the guidance is intended to facilitate and streamline the regulatory procedures associated with placing new products on the market. In particular, it allows medical device manufacturers to ask for and receive feedback from the authority with regard to the submission before actually filing it for review. The authority expects this approach to improve the overall quality of submissions, and also to help FDA with better allocation of its review resources.
In particular, the document describes in detail the Q-Submission process, including the steps to be completed. The document provides non-binding clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance with the applicable regulatory requirements. At the same time, provisions of the guidance are not intended to introduce new rules or impose new obligations, and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. Moreover, an alternative approach could be applied, provided such an approach is in line with the respective regulations and has been agreed with the authority in advance.
FDA Submission Tracking
In order to ensure the traceability of submissions, the authority assigns a unique identification number to each of them in accordance with the following rules:
- For original (initial) submissions, a number assigned will start with the letter “Q”, and also contain a two-digit reference to the year and four digits indicating the order. As explained by the authority, for the purpose of this rule, an original Q-Sub is the first Q-Sub submitted to the FDA to discuss a given device and its indications for use, a set of one or more devices/products intended to be used or marketed together, or a device “platform” upon which multiple devices will be built. The identification number assigned as described hereabove will be communicated to the applicant via email by the device of an acknowledgment letter indicating the identification number assigned, and also the date the request was received. This number should be used for all further communications with the authority. It is also important to mention that in the case of another review center involved, CBER, the procedure followed when assigning a unique identification number will be slightly different. In particular, the number will contain “BQ” instead of “Q” at the beginning.
- For supplements, an additional appending “/S” will be added to the initial number. For the purpose of the guidance, a Q-Sub supplement stands for any new request for feedback and/or a meeting about the same device with the same or similar indications for use as an original Q-Sub that already exists. This applies in the case of several consequent requests related to the same medical device having the same indications for use. As in the case of original requests, the approach applied by CBER is slightly different – there is no “S” added, just a slash “/“ to separate the original number and the reference number for a supplement request.
- For amendments, the appending “/A” applies (safe for CBER, where only slash is used as in the previous case). A Q-Sub amendment is any additional information relevant to the original Q-Sub or Q-Sub supplement that does not represent a new request for feedback and/or meeting; this additional information could include presentation slides, meeting minutes, minor clarifications, or requests to change contact information. As further explained by the authority, a Q-Sub amendment could be used, for example, to change contact information (in case of a change of submitter, an authorization letter will be required).
Meeting Information
According to the guidance, meetings are used to create a space for an open discussion and exchange of various important information related to the submission, the product in question, and aspects associated thereto. In the course of a meeting, the authority will provide additional information supplementing the written feedback on a Q-Submission and discuss the related matters. At the same time, the authority additionally emphasizes that submitters should not expect FDA to comment on new information provided by the submitter between receiving FDA written feedback and holding the meeting or during the meeting, as there is insufficient time for FDA to thoroughly review the information. Thus, if a submitter would like feedback on new information, such a request should be submitted as a supplement to the Q-Sub to allow adequate time for review, written feedback, and discussion of the new material, as appropriate. The authority also mentions that the interested parties should provide draft slides not later than 2 days before the meeting will take place in order for the authority to be able to distribute the information properly to all its staff involved in the process.
Apart from the above, the authority reminds that all the meetings under the Q-Submission program are subject to disclosure review in accordance with the Freedom of Information Act (FOIA). Consequently, all the materials associated with meetings, including various records and minutes, could be related upon a FOIA request safe for the cases when such materials contain information that constitutes a trade secret or is confidential.
As further explained by the authority, the most efficient way to conduct a meeting is to have a video/teleconference. However, in-person meetings are available upon request, so the interested party should contact the authority in advance with such a request. When requesting an in-person meeting, an interested party should communicate to the authority in advance the list of equipment needed.
Under the gnarl rule, the meeting duration is limited to one hour, which is optimal based on the FDA experience. Should the scope of submission be too wide to be discussed within one hour, the authority recommends limiting it in order to be able to focus on the most important matters.
In summary, the present guidance provides additional clarifications regarding the approach to be applied in order to ensure the traceability of submissions, including the way unique numbers are assigned to Q-Sub requests of various types. The document also addresses the aspects related to meetings and the way they could be conducted.
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