When the De Novo Classification Process May and May Not Be Used
Jun 20 2022
In accordance with section 513(f)(2) of the FD&C Act, you may submit a De Novo request for FDA to make a classification determination for the device according to the criteria. The De Novo request must include a description of the device and detailed information and reasons for any recommended classification. FDA must make a classification determination for the device that is the subject of the De Novo request by written order within 120 days of receipt of the request.
If the requester demonstrates that the criteria at section 513(a)(1)(A) or (B) of the FD&C Act are met, FDA will grant the De Novo request, in which case the specific device and device type is classified in class I or class II.
The granting of the De Novo request allows the device to be marketed immediately
Note that the classification, including any special controls, is effective on the date the order letter is issued granting the De Novo request. If the De Novo request is declined, the device remains in class III and may not be marketed, unless the device is found substantially equivalent to an existing legally marketed class I, class II, or preamendments device, the device is reclassified under section 513(f)(3) of the FD&C Act, a PMA is approved, or a new De Novo request is granted.
When the De Novo Classification Process May and May Not Be Used
FDA will review De Novo requests for devices that are not within a device type that has been classified under the criteria at section 513(a)(1) of the FD&C Act (21 CFR 860.200). This includes devices that do not fall within any existing classification regulation, where the De Novo requester either determines that there is no predicate device (21 CFR 860.200(b)(2)) or has received an NSE determination on a 510(k) submission (21 CFR 860.200(b)(1)).
If the device is of a type for which there is an existing classification regulation or one or more approved PMAs, the appropriate mechanism for classification into class I or II would be reclassification under section 513(e) or section 513(f)(3) of the FD&C Act.
For devices that have already undergone 510(k) review, FDA will consider a De Novo request if the device has been determined to be NSE due to:
(1) the lack of an identifiable predicate device
(2) a new intended use
(3) different technological characteristics that raise different questions of safety and effectiveness
Devices that have been found to be NSE due solely to performance data that is inadequate to demonstrate substantial equivalence (SE) would generally be ineligible for the De Novo classification process.
In considering whether to submit a De Novo request, the device should appear, based on what is known about the device, to meet the statutory standards for classification into class I or class II under section 513(a)(1) of the FD&C Act, i.e. (21 CFR 860.200(a))
Submitting a Pre-Submission for a De Novo Request
A Pre-Submission (Pre-Sub) is not required in order to obtain FDA review of a De Novo request, but it is a useful way for requesters to obtain early feedback from FDA and is therefore strongly recommended prior to the submission of a De Novo request, especially for devices we have not previously reviewed under a 510(k). A Pre-Sub allows FDA to provide feedback on whether a device may be eligible for the De Novo classification process, including whether a potential predicate device exists, and/or to advise you on the documentation needed in a subsequent De Novo request.
The primary advantage of a Pre-Sub is that it provides an opportunity to obtain our preliminary perspective on the likely regulatory controls necessary to provide a reasonable assurance of safety and effectiveness, as well as feedback on the evidence, including non-clinical and/or clinical data, that will likely be necessary to support the De Novo request.
By obtaining this feedback, you can optimize your resources in collecting the safety and effectiveness evidence needed to support a De Novo request, without performing additional unnecessary tests. This should also facilitate the review of a subsequent De Novo request.
Learn more details about Pre-Submission, read ' FDA, guidance of Pre-Submission '
Submitting a De Novo Request for FDA Review
510(k) Followed by De Novo Request
FDA determine that a device is NSE due to lack of
a predicate, a new intended use or different types of technology issues, and if we believe general controls or general and special controls may provide reasonable assurance of safety and effectiveness, FDA may indicate in the NSE letter that the product may be appropriate for the De Novo classification process under section 513(f)(2) of the FD&C Act. Inclusion of this language within an NSE letter does not indicate that sufficient information currently exists within the 510(k) submission to support a successful De Novo request, but simply indicates that given the risk profile of the device, it seems reasonable that De Novo classification may be appropriate.
2. De Novo Request – Acceptance Review
Once a De Novo request is received, whether or not it is preceded by a 510(k), FDA intends to conduct an acceptance review to make a threshold determination that the De Novo request contains the information necessary to permit a substantive review.
If your De Novo request is not accepted for review, the review clock stops and we will notify you that it is on hold pending receipt of additional information. In the event you do not provide the requested information within 180 calendar days, we will consider your De Novo request to be withdrawn (21 CFR 860.250(a)(2)).
Learn about FDA's review timeline for De Novo reguest, 'How to prepare a De Novo Request?'
3. De Novo Request – Substantive Review
After FDA has accepted the De Novo request for review, FDA will begin the substantive review of the De Novo request. As part of FDA’s substantive review, FDA intends to conduct a classification review of legally marketed device types. FDA intends to analyze whether an existing legally marketed device of the same type exists (e.g., whether your device likely falls under an existing class II classification regulation), including whether a predicate was established through the De Novo classification process. If a likely predicate device exists or your device falls under a class III classification regulation, your product is not eligible for De Novo classification and your De Novo re
quest will be declined (section 513(f)(2)(A)(iv) and 21 CFR 860.260(c)(5)-(6))
If the device falls within a class III classification regulation or there is one or more approved PMAs for the same type of device and FDA believes general and/or special controls are adequate to provide a reasonable assurance of safety and effectiveness, the appropriate mechanism for classification into class I or II would be reclassification under section 513(e) or 513(f)(3) of the FD&C Act. If no existing legally marketed device of the same type is identified, we will continue our review.
Once a De Novo request is granted, then the subject device may be used as a predicate for any future 510(k) submissions
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