Getting a product from inception to production isn’t easy, especially if you’re a medical device startup. However, knowing that your product could be life-changing makes it worth it. That’s why it’s important to know how to bring a medical device to market, and what it requires.
The FDA Medical Device Approval Process
Step 1. Classify your medical device.
Start by determining the type of device you’re bringing to market. The FDA has classifications for 1,700 different types of devices, which have been grouped into 16 medical specialties known as panels. Classifications are based on intended use, indications for use, and risk factors.
Step 2. Identify your premarket submission.
Your premarket submission will depend on the classification of your medical device, and will be identified as one of the following:
- De Novo Classification Request
- 510(k) Third Party Review Program
- Humanitarian Device Exemption
- Premarket Approval (PMA)
- Premarket Notification 510(k)
Step 3. Prepare your premarket submission for the FDA.
This is where important information about your medical device will come into play. When you prepare your premarket submission, you should include information about design controls, nonclinical testing, clinical evidence, and labeling. If your medical device is high-risk, then you’ll need to include additional information.
Step 4. Send your premarket submission to the FDA.
Once you’ve gathered all the essential information for your medical device, you need to submit it to the FDA for review. At this time, you should also include an electronic copy and associated fee if your medical device is classified as a 510(k) or PMA. Once the FDA receives your submission, they’ll complete a review that can last up to 180 days, depending on your medical device.
Step 5. Establish your registration and listing with the FDA.
Finally, you will register your establishment and list your medical device with the FDA. However, you should keep in mind that registration and listing for your medical device does not automatically denote clearance or approval by the FDA.
If you familiarize yourself with the process, you’ll know what to expect so you can confidently complete each step along the way, effectively bringing your product to market.
A medical device doesn’t do anyone any good if it’s not on the market. So, if you want to bring your idea for a medical device to market, you need to make sure that it follows these four requirements:
- It should be designed in a way that complies with regulatory requirements.
- It should be produced in a way that complies with regulatory requirements.
- It should receive required clearance or approval from the FDA, if needed.
- It should provide proven, documented value to the user.
Need Help Bringing Your Medical Device to Market?
Navigating the process of bringing a medical device to market is tricky. When you enlist the help of an expert, such as a medical device engineering and consulting company, you can get the help you need to successfully bring your product to market. With 25 years of experience, our team has helped everyone from small medical device startups to large corporations turn their ideas into reality. Schedule a free consultation with us today and get started with the insight and experience you need to get the job done right, including assistance with the FDA approval process.