Meeting the FDA’s regulatory requirements is an important component of any medical technology development project.
As you’re perfecting your innovation, engineering and designing your device, prototyping, and testing, you should also be delving into the FDA’s medical device panels and searching the product classification database to determine the correct classification for your medical device.
If you have the correct classification and device type, you can prepare your FDA premarket submission with confidence, regardless of your regulatory roadmap:
- FDA clearance through a 510(k) submission
- FDA approval through the Premarket Approval (PMA) process
- Permission to conduct a clinical study through an investigational device exemption (IDE) application
But what if you’re unsure of your medical device classification? Is there a way to get feedback from the FDA on the device type you’ve selected?
In this webinar, in2being co-founder and Director of Product Development Aaron Kehrer introduces the FDA’s 513(g) program.
Through a 513(g) request, you can learn the FDA’s opinion on:
- The classification of your medical device
- Regulatory requirements that apply to your device
Although there is a substantial fee to file a 513(g) request, it may be money well spent if it:
- Saves you from proceeding with an incorrect device classification
- Gives you clarity regarding FDA requirements for your device
- Ensures you’re preparing the right premarket submission [e.g., 510(k), PMA, etc.]
Your application should include the following:
- A description of your new medical device
- The proposed intended use for your device
- Proposed labeling and marketing materials
- Information regarding similar devices
in2being provides med-tech innovators with full-service consulting to help get life-changing or life-saving devices to market. Our services run the gamut from determining medical device classification and regulatory pathways to engineering, design, prototyping, testing, and more.
Contact us to learn how we can help bring your medical device into being.
Video Transcript
The 513(g) process is a way to get feedback from the FDA on your FDA medical device classification. When you have an idea for a device but are unsure if it falls under the definition of a “medical device” or are not clear whether you’ve chosen the correct regulation for your device, the 513(g) process is a way to get an answer from the FDA on both these questions.
The 513(g) submission will require some information about your device, including a description of the device, the proposed intended use, and any of your proposed labeling or marketing materials. It is also useful to include any material available for similar devices, which can aid the FDA reviewer in making their determination.
In addition, you’ll need to be registered in the FDA user fee system and pay a fee. If you are a small business, there is a reduced fee.
After receiving your submission and fee, the reviewer may reach out to request additional, clarifying information. Response to these requests in a timely manner will keep your submission on-track.
Once the reviewer has made their determination they will respond with a statement saying either:
- Your device is a medical device and subject to certain regulations and submissions before being placed on the market
- Your device is not a medical device
- Your device is what is called a combination product and will need to be examined by the Office of Combination Products to determine who has final say on it’s approval
If you want to explore related topics or additional information, there are links in the description.
Whether your regulatory pathway is clear or confusing, in2being can help. Contact us to learn how in2being can become your medical device development partner.