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Centre for Law, Medicine and Life Sciences

Faculty of Law

The recent ‘De Novo’ pathway is a regulatory initiative of the FDA. It offers a less burdensome path to market than previous regulation, which encourages innovation for moderate-risk medical devices. Dr Ariel Stern and LML members Prof. Mateo Aboy and Dr Cristina Crespo evaluate the changes in their recent article.


The three compare two US FDA’s regulatory pathways for moderate-risk medical devices: the historically dominant pathway of the 510(k) process and the De Novo pathway. The De Novo pathway, the authors argue, holds significant potential for innovators seeking to define new categories of medical devices, allowing the FDA to modernise its process. It will help encourage manufacturers to adopt the newest technologies and modern standards of safety and effectiveness.


Nevertheless the authors note several challenges with the De Novo pathway for medical device regulation, particularly for software and AI-enabled devices. These include:

  • Intellectual Property: Protecting the proprietary aspects of novel devices while navigating the regulatory process.
  • Innovation Incentives: Balancing the need for rigorous safety standards with the encouragement of innovation in the medical device sector.
  • Competition Economics: Ensuring that the market remains competitive and that new entrants have fair opportunities to participate.
  • Regulatory Modernisation: Updating the established 510(k) pathway to reflect current technologies and safety standards.


The article can be accessed here.