SiNtx Technologies Inc (SINT)

[boston745]

2 Types of NSE rulings. IF Type 1 mgmt could pursue De Novo route which takes up to 60 days to determine classification. If type II, they will need to gather more data to fulfill FDA requirement and submit a new 510k.

Generally, NSE determinations fall into two categories: (1) those that reflect FDA’s affirmative determination that the device is a Class III device and cannot be reviewed in a 510(k) submission, and (2) those that reflect inadequacies in the evidence that preclude a finding of substantial equivalence.

The first category of NSE determinations includes a variety of different decisions, such as a finding of a lack of a predicate device, a new intended use, or different technological characteristics that raise different questions of safety or effectiveness when the new device is compared to the cited predicate device that as a matter of law result in an NSE determination. When FDA issues an NSE letter for a reason in this first category, the letter will typically not identify performance-based deficiencies. Consequently, the device is automatically classified into Class III and will require PMA approval or, if eligible, granting of a De Novo petition[12] before marketing. If FDA believes that the device found NSE may be eligible for the De Novo petition program, the NSE letter will typically indicate FDA’s recommendation.

The second category of NSE determinations is for those devices for which FDA has not affirmed that the new device has a different intended use or that the different technological characteristics raise different questions of safety or effectiveness when compared to the cited predicate device, but rather that the information provided in the submission is insufficient to demonstrate substantial equivalence to the predicate device. In this situation, FDA generally first identifies the specific additional information — typically related to performance testing — that needs to be provided so that FDA may complete its evaluation of substantial equivalence. Upon receipt of FDA’s request for additional information (either through a formal letter, email, phone call or fax), the manufacturer has the opportunity to respond to FDA’s request. If the manufacturer does not provide the requested information or an adequate justification, or if the responses are insufficient, FDA will find the new device NSE. FDA will work with the manufacturer to try to resolve identified deficiencies but expects manufacturers to work with FDA staff in good faith and in a timely manner. If the manufacturer does not respond at all to FDA’s request for additional information, the submission will be subsequently withdrawn by FDA within the timeframe specified by regulation and guidance.[13] In either case, the manufacturer may submit a new 510(k) with additional information that addresses the outstanding deficiencies communicated by FDA based on review of the prior 510(k). If a new 510(k) is submitted to address deficiencies raised in this type of NSE letter, FDA recommends that the new 510(k) clearly identify how the outstanding issues have been addressed and clearly identify whether the information submitted in the new 510(k) was previously submitted in the prior 510(k) that FDA reviewed or constitutes new information. Citation of the prior 510(k) number is strongly recommended.

Section IV.A.3

De Novo is used when the device is not believed to be a Class III device but has no predicate device on market. FDA takes up to 60 days to determine classification before clearing the product for marketing.

De Novo