De Novo

In December 2018, FDA proposed improvements to the De Novo pathway for new medical devices to promote safe, effective and innovative treatments for US patients within a reasonable time frame. This is why the FDA has improved the "de novo" process.
The De Novo is a path of approval for innovative medical devices that would automatically be in class III for FDA, having to go through a PMA.
However, many new products are not at high risk and even though they can be considered as significant changes relative to products already on the market, they do not produce a significant increase in risk.
You can consider submitting a "de novo" request if the FDA determines, through means such as 513 (g) or Pre-Submission, that the device is a "novel device" without any Product code, Regulation number or Predicate device on the US market. In this case with the De Novo procedure, within 120 days, FDA will determine if the device is Class I or II and could issue a completely new product code and a regulation number. In case of rejection, the device will remain class III.
Maytal, through the experience gained in over 10 years working with FDA, is able to help the company through three fundamental steps for the success of a De Novo:
  • Gap analysis to present a De Novo, assisting the company in defining the Intended Use for the US market, classification, identification of similar technologies present on the US market (potential predicate devices), identification of the necessary documents for the De Novo and analysis of those available in the company, to assess suitability and completeness, with particular attention to clinical data available.
  • Technical-regulatory consultancy, thanks to its technical experts (engineers, biologists, clinicians) to support the company in the development/adjustment of existing documentation such as:
  • Drafting of the dossier for filing "De novo" application. When all the required documents and information are ready, MAYTAL will be able to prepare the file for the final presentation of the De Novo to FDA and will support you in communication with the FDA until the FDA's response is obtained.