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.

 

 

 

Regulatory approval is just the beginning of your medical device journey

Attention MedTech Innovators and Entrepreneurs

 

Regulatory approval is just the beginning of your journey to market success!

One of the greatest misconceptions in the world of MedTech is the singular focus on regulatory approval. While crucial, it’s merely the starting line, not the finish. Let’s debunk some common myths together:

💡 **510(k) Shortcut? Not Always!**
While the 510(k) route may seem like the easiest and cheapest path, especially for “me too” devices, remember, convincing end-users to switch requires evidence. Medical providers are understandably hesitant to change when they already have functioning solutions.

💡 **Breakthrough Designation: Not a Magic Bullet!**
Attaining Breakthrough Designation isn’t a guaranteed shortcut either. Truly novel devices may lack existing reimbursement codes, necessitating clinical data for gaining reimbursement status. Quick doesn’t always mean easy.

💡 **Exit Strategy Fallacy!**
Thinking only about positioning for an exit overlooks the crucial aspect of long-term viability. Investors and Strategics seek devices with the highest potential for commercial success. Market access alone isn’t enough.

This tunnel vision has led many promising companies to fall short of their goals.

✨THE BIG IDEA ✨
Identify and follow the regulatory path that aligns best with your company’s goals (not your predicate). Embrace clinical studies; they’re not as daunting as they seem! Craft a commercial plan that’s proactive, far-sighted, and tailored specifically to your product.

🚀Let’s reshape the narrative and shift to comprehensive success. 🚀