Webinar title:
US FDA Pre-Submission Best Practices for Early-Stage Startups and Small Businesses
Speakers:
Kristen and Mridul Mittal
Date:
September 2023
Summary:
In this beginners’ podcast, Kristen and Mridul Mittal explain what US FDA pre-submissions are and what purpose they serve, as well as how they work and how long they take. They discuss the FDA guidance designed to help applicants understand the pre-submission process, and provide practical advice for applicants wanting to use the pre-submission process to ensure everything runs smoothly and effectively.
Watch or download:
Timestamps/chapters:
- 00:00 – Introduction and guest overview
- 02:37 – What are FDA pre-submissions (Q-submissions)?
- 05:07 – Why early-stage companies benefit from FDA engagement
- 07:06 – How the FDA pre-submission process works
- 12:56 – FDA guidance documents and best practices
- 15:24 – Maximising the value of a pre-submission
- 19:22 – Should companies use the pre-submission process?
- 22:55 – Closing remarks
Full webinar transcript:
Chapter 1 – Introduction to FDA Pre-Submissions and the Guests
00:00
Marija:
Hello and welcome to today’s Medical Device Regulatory Podcast, presented by the Journal of Medical Device Regulation. With this podcast, we intend to bring some clarity to medical device professionals by discussing topical regulatory issues that are either important on a global level or that have sometimes a rather local or regional focus.
My name is Marija and I’m very excited to welcome today’s guest speakers who are joining us from Portland, USA, Mrs. Kristen Mittal and Mr. Mridul Mittal. They are the founders of Mittal Consulting and provide medical device regulatory strategies and submissions to all major governmental agencies, especially to startup companies and early-stage medical device developers.
In this session, we will ask them about ways to successfully conduct device pre-submissions to the US FDA.
By way of introduction, could you please tell us a bit about yourself and your role in the medical device industry?
Kristen Mittal:
Hi, I’m Kristen Mittal. I have undergraduate and graduate degrees in Biomedical Engineering and over 10 years of regulatory experience across medical device companies of all sizes, including Fortune 500 organisations such as Stryker and Johnson & Johnson, as well as startups. My background has focused primarily on active implantable medical devices.
Mridul Mittal:
My name is Mridul and I run the marketing and business development department at Mittal Consulting. Originally, I’m from India, but I now live and work in Portland, Oregon. My background is in bringing people and services together through innovative products. Together with Kristen, we’re working to help fill a much-needed gap in the MedTech regulatory industry.
Chapter 2 – Understanding FDA Q-Submissions: Purpose and Benefits
02:37
Marija:
We are here today to talk about FDA pre-submissions. What are they exactly and what purpose do they serve?
Mridul Mittal:
FDA pre-submissions are also known as Q-submissions. The terms are used interchangeably by the FDA. A pre-submission is a formal written request submitted to the FDA by a medical device manufacturer. Q-submissions are often used to initiate communication with the FDA before an eventual marketing application such as a 510(k), PMA, or IDE. Their purpose is to obtain FDA feedback on product-specific questions.
Marija:
Are they mandatory?
Kristen Mittal:
No, absolutely not. In some cases, the pathway is very straightforward and there is no need for a pre-submission. Companies can proceed directly to a 510(k) submission. However, if there are uncertainties, for example around testing methods, sample sizes, or interpretation of guidance documents, a pre-submission can help clarify expectations and reduce the risk of having to repeat testing later.
Mridul Mittal:
Pre-submissions can be used throughout the device lifecycle, but they are particularly beneficial for companies introducing a new device to the market. They help companies understand the FDA’s current thinking about their product and regulatory strategy.
Chapter 3 – Why Startups Should Engage Early with the FDA
05:07
Marija:
Why do you think startups in particular should use this service?
Mridul Mittal:
Anyone can use the programme, but startups often benefit the most because it may be their first interaction with the FDA and their first product entering the market.
Kristen Mittal:
Many early-stage companies are hesitant to approach the FDA because the process feels unfamiliar. However, we’ve consistently found pre-submissions to be extremely valuable. For novel technologies especially, they provide an opportunity to educate FDA reviewers about the device before the formal submission arrives. Large companies often have ongoing dialogue with the FDA through regular meetings. Startups typically do not have that relationship, so pre-submissions help establish it.
Chapter 4 – Inside the FDA Pre-Submission Process
07:06
Marija:
How do pre-submissions work, and how long do they usually take?
Mridul Mittal:
One of the advantages of the programme is that there is no FDA user fee associated with a standard pre-submission. The process begins with a written application requesting FDA feedback. Companies may also request a follow-up meeting to discuss the Agency’s written comments. Traditionally, those meetings were often conducted in person. Since COVID-19, however, teleconferences and virtual meetings have become the norm.
The submission should provide enough detail for the FDA to understand the device and answer the questions being asked. Topics typically include:
- Device purpose and intended use
- Device description and functionality
- Indications for use
- Regulatory history
- Specific questions requiring FDA feedback
Kristen Mittal:
For a standard pre-submission, the FDA generally follows a timeline of approximately 70–75 days to provide written feedback and schedule a meeting. It’s also important to understand that FDA feedback received through the pre-submission process is non-binding. Companies can ultimately choose a different approach if they later develop a sound scientific rationale.
Mridul Mittal:
Typically, it takes a company one to two months to prepare a quality pre-submission package before submitting it to the FDA.
Chapter 5 – Navigating FDA Guidance and Regulatory Expectations
12:56
Marija:
Has the FDA published guidance documents to help applicants understand the pre-submission process?
Kristen Mittal:
Yes. The key guidance document is titled: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The FDA periodically updates this guidance. It provides detailed information about preparing and managing pre-submissions.
One important point is that FDA guidance documents are technically recommendations rather than laws. You’ll notice that every guidance states that manufacturers are not required to follow it. However, guidance documents represent the FDA’s current thinking. Therefore, it is generally in a manufacturer’s best interest to follow applicable guidance documents closely and provide strong justifications for any deviations.
Marija:
So the FDA is essentially being polite when they say you don’t have to follow the guidance?
Kristen Mittal:
Exactly. They’re acknowledging the legal distinction between guidance and regulation, but in practice, guidance documents are often the framework reviewers use when evaluating submissions.
Chapter 6 – Strategies for Successful FDA Interactions
15:24
Marija:
What advice would you give to companies wanting to get the most out of the pre-submission process?
Kristen Mittal:
One of the most important considerations is how you formulate your questions. The FDA allows multiple questions within a pre-submission, but vague questions tend to receive vague answers. If you simply ask, ‘Do you agree with this testing plan?’ you’ll often be referred back to existing guidance documents. Instead, questions should be highly specific, for example regarding sample sizes, test durations, endpoints, or protocol details.
Another important consideration is planning. Most companies will use the pre-submission process multiple times throughout development. Since FDA review timelines can take several months, companies should strategically schedule pre-submissions to avoid delaying product development.
Meeting preparation is equally important. Companies should ensure that the appropriate subject matter experts attend the meeting and that everyone understands the objectives.
Because FDA meetings are often limited to about one hour, discussions should remain focused on the agreed topics rather than expanding into unrelated development issues.
Chapter 7 – Risk Reduction Through Pre-Submissions
19:22
Marija:
Would you generally recommend that companies use the pre-submission process, or should they simply proceed directly to marketing authorisation?
Kristen Mittal:
In most cases, if there are meaningful questions that require FDA input, I would recommend conducting a pre-submission.
The biggest advantage is risk reduction. Without FDA feedback, companies may interpret requirements differently than the Agency intended, potentially resulting in additional testing or delays later in the process.
Another benefit is that pre-submission discussions become part of the regulatory record. If agreement is reached regarding testing strategies or rationales, that information can support future submissions.
Ultimately, the regulatory process is about reducing uncertainty. Pre-submissions are one of the most effective tools available to help align a company’s development strategy with FDA expectations.
Marija:
I also assume that much of the documentation created for the pre-submission can later be reused in the marketing application.
Kristen Mittal:
Absolutely. Device descriptions, indications for use, and many foundational elements developed during the pre-submission process often become building blocks for the final submission package.
Chapter 8 – Closing Remarks
22:55
Marija:
Kristen and Mridul, it was lovely talking to you. Thank you very much for your insights and for sharing your perspectives with us.
Kristen Mittal:
Thank you so much for having us. We really enjoyed the discussion.
Mridul Mittal:
Thank you, Marija. It was great to be here and discuss the FDA pre-submission process with your audience.
Marija:
Thank you so much. Talk to you soon.
