November 2, 2022

Clearing The FDA Bar – The Steps To Bring Your Medical Device To Market

The Food and Drug Administration or FDA regulates the sale of medical device products and examines their safety and efficacy in the US. If you plan on joining the club of legal medical device sales in the, going through the FDA is your ticket inside. The device development process can look different based on what you plan on bringing to market. But don’t feel intimidated, here’s an overview of what you need to be aware of so you can hit the market with your medical device as soon as possible.

How To Get FDA Clearance – A Step by Step Overview

Device Classification – Knowing your device’s categorization will be the first step toward FDA clearance. Medical devices can vary widely in their design and goals. To address this, the FDA has provided different classifications based on the risks a medical device may pose to consumers. Let’s look at the different classes so you can get schooled on where your device fits in.

  • Class I – Medical devices in this category pose the most negligible risks to consumers. Think bandages and stethoscopes. Devices like these are subject to general control that ensures the safety and effectiveness of the device after manufacturing. While devices in this category require premarket notification known as 510(k), they are not subject to premarket approval.
  • Class II – Devices in class 2 pose a higher risk to consumers and are susceptible to both general and special controls. The special controls in the classification include labeling requirements, specific mandatory performance standards, and specific testing requirements. Class II devices aim to demonstrate that they are substantially equivalent to a similar product that has already received FDA clearance. You might find devices like syringes and contact lenses in this category.
  • Class III – These devices are made to support or sustain life, implemented inside the human body, or risk inflicting injury or disease to the user. This includes devices like pacemakers and cochlear implants. Producers must provide the safety and efficiency of the product coupled with general controls. These devices also require pre-market approval.

Prototype Development – Developing a prototype is the second stage in the development process. Prototypes in this stage won’t be ready for human use but instead be used for testing in laboratory environments. This will help reduce risks before human use. Then, the device may continue on to clinical trials

Application Submission – After the prototype stage it’s time to submit an application to the FDA for review. Once you have filed your application, the FDA will conduct a thorough evaluation of your product. As a part of the application process your device will require FDA verification and validation.

FDA verification makes sure the requirements you set for your product are fulfilled. You should ask yourself, am I designing the device right? You can answer yes if your requirements are implemented, verified, and that the requirement standards are met.

FDA validation on the other hand asks the question, are you designing the right device? Your device should meet the needs of users, internal stakeholders, and regulatory stakeholders.

Waiting for Review – No one likes waiting, but this step is how the FDA determines that your device meets the requirements.

Maintain FDA Compliance – Obtaining approval from the FDA doesn’t end the process like you might expect. You will need to ensure that your product maintains compliance for its lifespan. While the process may seem long and arduous it ensures the safety and efficacy of medical devices on the market. Learn more about how PrimePath can help you with these steps and you’ll be on your way to introducing the world to your newest life-saving product. (Or the latest in tongue depressor technology if that’s what you’re after).