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How will your Q-Submission be tracked by the FDA?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

FDA assigns a unique identification number to all Q-Subs as described below.

Original

An original Q-Sub is the first Q-Sub submitted to 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.

Original Q-subs submitted to CDRH will be assigned a number starting with “Q” followed by two digits representing the year, and four digits representing the order in which the request was received during that calendar year. For example, the first original Q-Sub received by CDRH in January of 2018 will be identified as “Q180001.” FDA will send an acknowledgement letter via e-mail to the contact identified in the Q-Sub cover letter that contains the unique tracking number and date received by the Document Control Center (DCC). Any future communications regarding your Q-Sub should include this unique Q-Sub identifier.

Because of organizational differences between CBER and CDRH, the process described in the preceding paragraph is not applicable to submissions sent to CBER. Q-Subs submitted to CBER will instead be assigned a number starting with ‘BQ’. After the CBER DCC processes your Device Q-Sub, it will be forwarded to the appropriate Product Office for additional processing and review. You will be contacted by the RPM who will provide you with a BQ number and who will be your contact for all additional communications.

Supplement

A Q-Sub supplement is any new request for feedback and/or a meeting about the same or similar device and indications for use as an original Q-Sub that already exists. For example, it may be appropriate to request an Informational Meeting to familiarize the review team with the new device design, then submit a Pre-Sub to request feedback on nonclinical testing, then a Study Risk Determination Q-Sub for the pivotal clinical study, all for the same device with the same indications for use. The first Informational Meeting in this example would be the original Q-Sub, while the Pre-Sub and Study Risk Determination Q-Sub would be tracked as supplements to that original Q-Sub.

At CDRH, each supplement is tracked by appending “/S” after the original followed by a three-digit sequential number, e.g., the first supplement to Q180001 will be identified as “Q180001/S001.” At CBER, “S” is not used, only the slash (/) is added.

Amendment

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.

If you need to change contact information, such as submitter organization or correspondent (e.g. consultant) organization, you should submit a Q-Sub amendment to your original clearly stating the change. Note that if you need to change the submitter, the Q-sub submitter of record (the submitter recorded in our system) should provide a letter authorizing the change in submitter. If you do not need to change the submitter, but want to change the correspondent, there are two possible scenarios:

  • changing the correspondent organization and
  • changing just the correspondent contact person.

If the submitter wants to change the correspondent organization, such as adding or removing the use of a consultant, then the submitter should submit the change stating the new correspondent organization and providing the name, email address, and phone number of the new primary contact in that organization. If you would like to use a different correspondent contact person for a given supplement, you do not have to submit an amendment; you can indicate the appropriate correspondent contact person when you submit that supplement.

At CDRH, each amendment is tracked by appending “/A” after the original or supplement to which it applies. For example, the first amendment to Q180001 will be identified as “Q180001/A001,” while the first amendment to Q180001/S001 will be identified as “Q180001/S001/A001.” At CBER, “A” is not used, only the slash (/) is added.

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