Hi Jenna - Similar to what Richard said, you need to demonstrate due diligence in making sure there isn't a viable predicate device (510(k)) or a similar device already approved through a PMA. In essence, you want to present a coherent argument to explain that your device is fundamentally different from all other devices currently classified and regulated by FDA, in terms of intended use and/or fundamental technology.
Submitters take many different approaches to this depending on the type of product. For some products, it is so unique that an exhaustive search probably isn't necessary; you can likely just focus your search on a few regulations/product codes. For others, it may be similar enough to other existing devices that you'l need to be more nuanced and widen your search.
The safest and most exhaustive way to determine eligibility on your own, in my opinion, is as follows (this is exactly what the FDA review team does when they receive an original De Novo):
1. Identify search terms that you believe would most likely generate products possibly similar to your device. These are usually based on words stemming from the intended/indications for use and fundamental technological characteristics.
2. Use these search terms in each of the public databases (eCFR, product codes, 510(k), PMA, De Novo)
3. For each search result, explain why your device is fundamentally different (e.g., new intended use, new indication that represents a new intended use, different technology that raises different questions of safety/effectiveness, different/new risks to health)
4. Your device must be different from everything you find in your search.
The absolute safest way is to ask FDA! While you can submit a 513(g), I can't recommend enough the use of the pre-submission process to ask the FDA team directly about regulatory pathway, based on your research. If the review team believes your product is eligible for De Novo classification, then you're golden. Of course, the pre-sub process is also a good way to understand FDA's expectations for data and evidence to support De Novo classification of your new device type.
Hope this helps,
Sergio
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Sergio de del Castillo
De Novo Program Lead
Silver Spring MD
United States
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Original Message:
Sent: 31-Aug-2020 16:46
From: Jenna Horsley
Subject: De Novo Submission
For De Novo submissions, does anyone know what the expectation is as far as determination for eligibility beyond that which is contained in the FDA guidance? What is the best way to make the argument that your device does not fall into any existing classification? How many searches for predicates do you have demonstrate? Are they looking at a comprehensive report of everything? How do you determine what is sufficient? The guidance states:
"The De Novo request includes a classification summary that explains why the subject device is eligible for De Novo classification,
including: The searches used to establish that no legally marketed device of the same type exists. Based on the searches, a list of the classification regulations, PMAs, 510(k)s, and/or product codes regarding devices that are potentially similar to the subject device. A rationale explaining how the subject device is different from the devices covered by the classification regulations, PMAs, 510(k)s, and/or product codes identified in the searches.
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Jenna Horsley RAC
Senior Regulatory Affairs Manager
Cambridge MA
United States
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