Let the Q-Sub (or Pre-Sub) be your first contact with the FDA
Every medical device company entering the US market, comes in contact with the FDA. Even if only to register the company or a Class I device on the FDA database. If you have a product that’s Class II or III, the Q-Sub or Pre-Sub meeting should be your first contact.
Unfortunately, 70-75% of all first-time 510(k) submission are rejected. Clearly, medical device companies can use early feedback from the FDA, saving money in wasted effort.
But what if your path is not quite clear. How do you get clarity regarding your product’s classification? Whether or not you have to submit clinical studies as part of your 510(k)? And will those be considered significant (SR) or non-significant risk (NSR)?
The FDA has implemented a process whereby Medical Device companies can ask for advice. The FDA will grant requests to discuss questions regarding:
- Pre-510(k) or Pre-PMA Submissions
- Investigational Device Exemptions (IDE)
- Clinical and non-Clinical Study Protocols
- Breakthrough Designation,
The FDA calls the process a Q-Submission meeting after its Q-identification number. The FDA refers to these meetings as Q-Subs. A Pre-Submission meeting (or a Pre-Sub) is a specific type of Q-Sub meeting.
As testimony of the usefulness of the process, the FDA received 2,707 requests for a Pre-Sub during FY 2018. They wrote 2,593 feedback reports and held 1,502 meetings. And the Pre-Sub is absolutely FREE!
Be Deliberate with your Q-Sub/Pre-Sub
As the FDA has the power to allow or refuse market access for their product, medical device companies are typically very deferential.
Some firms afraid of making a poor first impression, are reluctant to ask for advice. They fear it could jeopardize the process and put approval at risk. And, they should be. But not for the reasons they think: the FDA wants the requesting party to be properly prepared for the meeting. Lack of such preparation may lead the FDA to refuse the request, or failure of the sought-after meeting.
Others ask the FDA to resolve questions without demonstrating that they have thoroughly considered these questions themselves. Or they ask for advice without forwarding the proper information on which a decision has to be based.
Familiarize yourself with the Q-Sub/Pre-Sub process. Get help if needed.
Sometimes, foreign companies are not familiar with the US regulatory pathways. They may base their actions on anecdotal experiences shared by companies in their cluster. Unfortunately, such anecdotes do not always reflect current. thinking. And, as we all know, they often grow by each telling.
Overseas companies may or may not know about the existence of the Q-sub process. And even if they do, they often lack understanding of what the process entails, and how they should properly prepare.
A European company recently contacted me. They set up an office in the US with the explicit purpose of obtaining market approval. Shortly afterwards a local employee contacted the FDA. The employee provided background on the product and requested a vague and ambiguous Q-sub. The FDA was sufficiently intrigued by the company’s product that they did not issue an RTA (Refusal To Accept).
Instead, the FDA referred the company to their guidance document. And requested the company forward the underlying data needed to discuss the questions within the next 30 days?
Finally, the requesting company realized they needed to gather a significant amount of data to support their request. They requested extra time and were granted 90 days.
Tips for your next Q-Sub/Pre-Sub
Yet, the process is pretty simple and laid out in an FDA guidance document: Requests for Feedback on Medical Device Submissions. Add the required documentation, choose whether you want written feedback and/or a meeting (if so, add some future dates you are available – 75 to 90 days out). Readers who want more FDA information may want to review the FDA webinar on the subject: Q-Submission Program for Medical Device Submissions, June 11, 2019
While the very best questions are often yes/no questions: “ Is this predicate acceptable to the FDA?”, “Will the FDA consider this protocol for a clinical test adequate?”, the preamble to the question needs to be detailed and specific, offer the evidence on which you based your proposed decision and explain the reasons behind the decisions you have made.
As you prepare for your meeting make sure to clearly understand your intended use statement. If you want to discuss the written feedback with the FDA, limit the number of team members invited to the meeting. The FDA will match your experts one by one. With too many people needing to chime in, the one hour allotted for the meeting may not allow you to work through a challenging agenda. And set no more than 3 or 4 objectives for your meeting.
Warning: feedback from the FDA is not binding. As time passes, the FDA’s understanding of certain matters may evolve. Make sure to hold your Pre-Sub sufficiently close to the time you will submit. Or request an additional Pre-Sub closer to your final submission. There exists no limit to the number of Pre-Subs you can request.