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This video is part of an ongoing series of “droplet” videos intended to communicate key concepts in the medical device development process.

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.

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