In the simplest of terms, the FDA’s Q-Submission (Q-Sub) program is a voluntary process in which sponsors or submitters can engage and request formal feedback from the FDA. This feedback is in response to specific questions raised by the submitter, often related to product development and/or preparation of a pre-market application.
For industry, the Q-Sub program is a way to potentially establish a more efficient path to market from device concept by enabling better use of resources (both time and money). For the FDA, this means getting better quality pre-market submissions that have minimal or no deficiencies.
It also means the FDA may have a chance to become acquainted with new technologies or new technical issues prior to full pre-market submission to review. Ultimately, this interaction is encouraged to foster development of new medical devices.
Background of FDA’s Q-Submission program
The Q-Submission program has evolved from the pre-Investigational Device Exemption (Pre-IDE) program established in 1995, which provided sponsors with a mechanism to obtain FDA feedback on devices prior to their IDE submission.
The utility of this feedback under the Pre-IDE program was acknowledged and expanded to other types of pre-market applications via a more comprehensive Pre-Submission program. This Pre-Sub process was further developed into the broader Q-Sub program, which most recently received a refresh in May 2019.
Which Q-Sub is right for my device?
There are multiple types of Q-Subs, which should be chosen depending on specific circumstances and/or questions to be asked. Feedback for a Q-submissions comes in the form of a written reply, teleconference, and/or face-to-face meeting. The response time for a Q-Sub is typically 60-75 days, or around 21 days for vital public health issues. The various types of Q-Subs are as follows.
- Pre-Submission (Pre-Sub)
- Submission Issue Request (SIR)
- Study Risk Determination
- Informational Meeting
- Breakthrough Device Designation Request
- Accessory Classification Request
- PMA Day 100 Meeting
- Formal Early Collaboration Meeting
There are three main feedback mechanisms that the FDA will utilize. Written feedback is the default response and may alone be sufficient in some cases (without further interaction with the FDA). Written feedback will also be provided at a minimum and ahead of either a teleconference or face-to-face (F2F) meeting.
The teleconference meeting is the most widely utilized feedback mechanism as the face-to-face approach is time and resource intensive. However, there are clear cases where a face-to-face meeting will be beneficial. For example, if a submitter requires a hands-on approach in explaining the device and its function (e.g., surgical approach, unique delivery system, etc.), An in-person meeting would be helpful.
How NSF International can help with your FDA Q-Sub request?
NSF International, a global leader in the development of public health standards and medical device certification programs, offers hands-on regulatory consulting to guide device companies through the Q-Submission process, tackling any specific needs.
Additionally, NSF’s e-Learning module ‘Requesting FDA Feedback: The Q-Submission Program and Meetings with FDA Staff,’ which can be completed in just two hours, provides potential applicants with valuable tools to prepare a quality Q-Sub that will convey the information required for prescriptive FDA feedback. Applicants are awarded the Medical Device Certificate upon completion of the module.
Regulators, manufacturers and consumers look to NSF for the expansion of certification programs and public health standards that help to look after the world’s water, food, environment and consumer products.