The streamlining of processes is cost-effective in most cases as far as consistency and conformity across the board.  “On October 5, 2021, FDA issued a final rule on the De Novo Classification Process.3 This final rule will add new regulations at 21 CFR Part 860, Subpart D--De Novo Classification that describes the procedures and criteria FDA will use in assessing whether a request for an evaluation of automatic class III designation.” (FDA, 2017) The goal of the FDA is to set up a systematic way of making the application and review process at a 70% performance level by this fiscal year 2022 for the MDUFA decision. I believe this process holds FDA accountable to a time clock that is reasonable for novel devices that would ordinally be classified as class 3 in the 501 (k) process the option to come to market based on overall risk analysis. If companies can provide substantive results and prove risk level of medical devices and have supporting data and documentation it is a win-win process. The De Novo 510K process takes 180 days from start to finish. Once an application is submitted to FDA for review, the company has the opportunity to comply with any additional request by FDA or withdraw the application. I think this process places equal responsibility on the FDA and the company to do due diligence in testing, risk analysis, market response, before wasting so much time in trying to classify the medical device under the PMA or 501 (k).

De Novo is a classification process using a risk-based strategy for new, novel devices that have not been classified as of yet. This new ruling expediated the process by creating an alternative pathway that does not require submission of a 510k prior to a de novo request. Before this ruling, a company would have to submit a 510k, the FDA would review it, and then they would determine if that new device had no substantial equivalent, and they would automatically classify it as Class III, and the company would have to submit a de-novo application to try to have it down classified. Now companies are going directly to a de-novo application.

This new process is a good thing because it will allow lower-risk devices to not be classified as Class III groups. I think this will substantially reduce the amount of work that will be involved in having to file extra paperwork if the FDA does consider the device risky.

The de novo request offers a marketing route to categorize novel medical devices for which general controls or general and special controls offer a reasonable assurance of safety and efficacy for the intended application but for which there is no legally marketed predicate device. A risk-based categorization approach is de novo classification. When the de novo process was first introduced, sponsors were required to submit the pre-market notification (510(k), where they had to demonstrate that they had substantially identical evidence and that they had a predicate company in place as a guide. Following this path, it was then decided whether to reclassify a class III device as a class I or a class II device. The 2014 change made it possible to use an alternative method that doesn't call for submitting a 510(k) before making a de novo request and provided a 120-day review window for the FDA. This change was great news because the pre-market approval pathway is typically very costly and takes quite a bit to get through.