Understanding FDA Pre-Submissions

The FDA Pre-Submission (pre-sub) program is a game-changer for medtech and pharma companies. It allows you to get valuable feedback from the FDA before your actual submission – it’s like having the answers to the test ahead of time. The best part? It’s completely free to submit a Pre-Sub. This step saves time, resources, and helps guide/derisk your submission strategy.

What is a Pre-Submission?

A Pre-Submission is a formal way to get feedback from the FDA. It usually includes written responses and can also involve a one-hour meeting. This helps answer important questions that can impact product development, testing, choice of similar products, or other parts of regulatory submissions like 510(k), De Novo, PMA, or IDE applications.

Benefits of a Pre-Submission

1. Did you know that the FDA strongly recommends taking advantage of a presub opportunity?
It provides an opportunity to discuss specific regulatory questions with the FDA, which can be particularly beneficial for devices using novel technologies or those classified as “first of a kind”.

2. Feedback on Pre-Clinical and Clinical Strategies: During pre-subs, companies often obtain directional feedback on verification and validation testing, which streamlines submissions. The FDA aims to provide feedback within 60 to 75 days of receiving a complete submission package, so it’s crucial to submit a Pre-Sub early in the development process.

Making Your Pre-Submission Impactful

The true impact of a pre-submission is in knowing what questions to pose to the FDA. RLS’s team of experts have the experience to identify the areas that will help eliminate regulatory or clinical risks information, and where the process is most likely to stall due to high-risk questions. We allow manufacturers to align their strategies with FDA expectations, saving time and resources for you to focus on bringing your innovative products to market.

 

 

 

Medical Device Commercial Path

medical-device-commercial path-infographic

Launching a medical device in the next 1-3 years?

Seeking funding for your medtech startup?
Investing in a startup company?

Here are pivotal milestones and their significance.

  1. Commerical due diligence is essential at this stage to clearly prepare for accurate funding and resources. Sadly, many companies encounter funding challenges by milestone
  2. Reg and Clinical strategies are key by this stage as they are critical to be prepared for FDA pre-submissions and mitigate any potential risks.
  3. Engaging investigators and proactively gathering all required data are vital as FDA negotiations and site selections can consume up to a year.
  4. Be ready to kick off your clinical study as soon as receiving the FDA (or ethics committee) greenlight.