Q-Sub – Yes or No?

Squelch Uncertainty

Uncertainty is Kryptonite to investors. If the team cannot confidently adopt a regulatory strategy and have confidence in the 510(k) application pathway, outside funding support may be reticent. The most important reason to file a Q-Sub is when you can’t afford to be wrong. The biggest risk to filing the Pre-sub before your team is ready and when the team has not adequately assessed the project risk and predicates is the possibility of triggering FDA’s concern your product could be “deNOVO” or require Premarket Approval (PMA).

Avoiding the cost of repeating expensive and time-consuming testing is another motivation for Q-sub. The bulk of time and money can be spent on any one or more of 1) biocompatibility testing, 2) preclinical assessments, 3) standards certification (such as to IEC standards) 4) validation trials such as usability studies, and of course, 5) clinical studies. When a company is facing these commitments, it can be important to confirm with FDA that the testing is necessary and that the proposed studies are able to demonstrate “SE” (assuming the product is a candidate for 510(k). The Pre-Sub process will not determine “SE” but when the Pre-Sub presentation includes basic information with well-balanced questions for FDA, the sponsor should know from FDA if proposed plans have met nominal requirements.
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Drafting the Pre-Sub can build cohesiveness

Advanced regulatory planning and strategy should be included in the Design Control and Review planning as early as possible. Agreement on product performance sounds simple, but it is amazing how many times team members don’t agree on how a new device will compare with existing alternative therapies and devices. Using a Pre-Sub template can help the team to focus on the information necessary to support the regulatory strategy. Developing a uniform presentation of the product information can help to highlight the potential unknowns. The process of writing the draft becomes a consensus building tool. Drafting a potential Pre-sub to the FDA is a great way to consolidate opinions about the new product among team members.

A Pre-Sub for an IDE Application is usually a very prudent plan. IDE review time with FDA is designed for 30 day review once submitted. Clinical trials are quite complicated and even if a study may be “non-significant risk”, no one wants to fail to plan for FDA’s expectations. Clinical trail data from outside USA may reduce or eliminate the need for a US clinical trial, but until we pull it all together it is difficult to determine gaps. Planning a clinical study Q-sub is ideal, even if you subsequently determine that it is not necessary.
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When do you need a Pre-Sub

Only after you have begun to lay the regulatory foundation should you begin to consider whether or not a Pre-Sub for a 510(k) could be of value. If you can confirm a straightforward, reasonably recent predicate cleared by the FDA for the same indication for use and intended use; and there are no major differences in technology, you probably don’t need to submit a Pre-Sub.

Analysis of similarities and differences can identify whether or not your new device has a difference that could impact a Substantial Equivalence decision (SE.) Sometimes a new product can introduce a new risk to patients compared to current products, possibly due to new technology/materials and FDA might require clinical data to process the submission. Testing requirements can vary due to new claims or different users, so having FDA concur with your validation plans can be a financial plus. If a product has been cleared for market in a different regulatory jurisdiction, a visit to FDA to discuss differences in labeling and testing can save many headaches during the 510(k) review.

There is always a risk that you won’t like the answers you get back from the questions you ask FDA. An ill developed Pre-Sub can engender less than ideal answers from FDA. We can’t guarantee that a Pre-Sub won’t open Pandora’s Box, but we certainly can reduce that opportunity to a minimum by carefully identifying the type of questions that need answers. The Pre-Sub should not become a “what-if” session. Respecting FDA’s perspective on a new product is critical to the final outcome. The Pre-Sub feedback from FDA does become part of the record for your product and you must reference the Pre-Sub outcomes when you file the submission.

If your team is uncertain of the device regulatory pathway, uncertain of the best predicate, the impact of a technology or different indication for use, we can help. We can provide guidance and templates to aid you in drafting a Q-Sub, help define the questions for FDA and help you time this step, if it is advisable. We can produce and submit your Q-Sub, if that is the right action to take. Our experience and advanced planning skills can help you avoid agony and remorse.

iRequests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: https://www.fda.gov/media/114034/download
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