Medical devices have traveled a long path throughout the past century, and we certainly believe that there are many more miles to go in this ever-evolving world. However, often we see a “Me Too” device rather than a “Me First” device. There could be myriad reasons for this; one common reason that we at Rook Quality Systems (RQS) have observed over the years is the “fear of getting lost in the turmoil of innovation”.
Innovation always starts with uncertainty: It’s always exciting to innovate for the greater good of mankind, but when it comes to market approval of your device, it may lead you to nowhere. For instance: To market your device in the US, one of the most common pathways to adopt is the Premarket Notification Pathway- also known as the “510(k) pathway”. In this pathway, a manufacturer identifies a competitor device and attempts to collect evidence that it is substantially equivalent to their device. However, in multiple instances we have witnessed that if this process is not well executed, it leads to either delay or rejection in the market approval process. If you are in a similar situation, then you are not alone. At RQS, we have received requests from numerous clients with innovative products, but without the regulatory vision to find an efficient and quicker pathway to the market.
For a “Me First” product, regulation was (and will never be) straightforward. However, to help the manufacturers, the US Food and Drug Administration (FDA) launched a program called the “Q-Submission Program” in order to provide a mechanism to the manufacturer or relevant organizations through which they can request feedback from (or a meeting with) the FDA regarding a potential or planned submission prior to marketing a device in the US.
The precursor to this “Q-Submission Program” was called the “Pre-IDE Program,” which was established in 1995. However, as the name suggests, this program was strictly limited to obtaining FDA feedback on future IDE applications prior to their submission. Over the years, this mechanism of receiving FDA’s feedback has evolved to include more and more different types of submissions.
What are the different types of Q-submission?
A Pre-Sub is usually submitted to the FDA to receive FDA’s feedback on a potential marketing application or related submission. Feedbacks are usually received in the form of written responses along with (if chosen by the submitter of the Pre-Sub) the opportunity to directly interact with the FDA personnel via teleconference or in person visit.
Submission Issue Requests (SIRs)
A SIR is usually submitted to receive FDA’s feedback on a proposed approach to address the issues conveyed by the FDA during the review process of a marketing application or related submission.
Study Risk Determinations
A Study Risk Determination is usually submitted in order to receive FDA’s feedback on whether a planned medical device clinical study is of significant risk (SR), or non-significant risk (NSR), or is exempt from IDE regulations.
These types of submissions are usually submitted without the intent to receive any feedback from the FDA. It may be submitted in order to make the FDA familiar with the ongoing development process of a new device which is significantly different from the device currently available in the market.
Other Q-Submission Types
In addition to the above mentioned submission types, there could also be other submissions such as:
- Submission for PMA Day 100 Meetings
- Submission for Agreement and Determination Meetings
- Submissions associated with the Breakthrough Devices Program
- Submissions associated with the Safer Technologies Program
- Submission for Accessory Classification Requests
Here are a few scenarios based on our experiences with previous clients who contracted RQS for their pre-submissions to clarify their regulatory, quality, and technical development strategies:
Scenario 1: You are uncertain about choosing the comparison device (known as the “predicate device”), which might potentially prevent you from pursuing the 510(K) pathway. For example: One client modified their software program to receive different input data types and tweaked the underlying data processing algorithm, given the potential regulatory challenge identified by the RookQS team upfront (e.g., high likelihood of receiving a non-substantial equivalence decision). This design decision was well informed due to the early regulatory planning, and prevented this application from potentially being considered as a De Novo application.
Scenario 2: You have no access to the predicate device. Hence, you are unsure how to proceed with the V&V studies to demonstrate substantial equivalence. The client was able to identify another reference device, operating based on a similar technological principle, and came up with a verification proposal agreed to by the FDA to demonstrate the performance specification being on par with both the reference device and predicate device.
Scenario 3: One software component of your proposed software as a medical device should be a lower classification device (e.g., medical device data system), and you would like to know if the FDA agrees with the designation and your reduced DHF proposal.
Scenario 4: You cannot identify a suitable predicate device. Hence, you would like to confirm with the FDA on your proposal for pursuing a De Novo pathway.
Scenario 5: You have received clearance from the FDA on respiratory rate monitoring indication in the past. Now, you are pursuing expanding the indication to heart rate monitoring, using the same exact hardware platform. You would like to confirm with the FDA regarding your proposal to leverage your previous clearance and reduce the resources needed to replicate certain technical development activities.
Scenario 6: You have a digital health application with intention to pursue medical claims down the road, but not with the initial product offering. You can confirm with the FDA on whether they agree that your initial product offering would not be considered as a medical device designation.
At RQS, we have extensive experience assisting manufacturers with all of the above Q-submissions regarding their devices. We have assisted manufacturers in preparing and submitting Q-submissions, as well as leading direct interactions (teleconference or in-person) with the FDA reviewers.
For expert assistance with your submission or device, look to Rook; we’re here to help.