Starting October 2025, the U.S. Food and Drug Administration (FDA) will require all De Novo classification requests to be submitted electronically, via the electronic Submission Resource and Resource (eSTAR) template, marking a significant shift in regulatory submission processes for medical devices. This transition aims to streamline the approval process and enhance the efficiency of device review and management.
The De Novo pathway is a regulatory process used for novel medical devices that are not substantially equivalent to any existing devices. This pathway allows for the classification of new types of devices and sets the stage for their market entry with appropriate controls to ensure safety and efficacy. It is particularly valuable for innovative devices that represent a new category of technology.
The eSTAR program was expanded to include devices submitting under the de novo pathway in December 2021. The move to electronic submissions is expected to have several benefits for both the FDA and device manufacturers:
- Enhanced Efficiency: Electronic submissions are anticipated to speed up the review process by facilitating faster data transmission and reducing the time spent on managing paper-based documents, likely leading to quicker decision-making and reduced time-to-market for new devices.
- Improved Accuracy: Digital submissions can minimize errors associated with manual data entry and handling enhancing the accuracy of the information reviewed by the FDA, supporting more informed regulatory decisions.
- Streamlined Workflow: Electronic submissions will enable better tracking and management of De Novo requests helping both the FDA and manufacturers monitor the status of submissions more effectively, improving overall communication and transparency.
- Environmental Impact: Moving away from paper-based submissions aligns with broader sustainability goals by reducing paper waste and lowering the environmental impact of regulatory processes.
- Documentation and Formatting: Manufacturers will need to adhere to specific formatting and documentation requirements set forth by the FDA for electronic submissions. Detailed guidelines will be provided to assist in preparing compliant submissions.
The electronic submission requirement will affect various stakeholders, including device manufacturers, regulatory consultants, and healthcare providers. Manufacturers will need to adjust their submission practices and invest in technology and training to comply with the new requirements.
Manufacturers and stakeholders are encouraged to stay informed about upcoming changes and prepare for the transition to ensure a seamless shift to electronic submissions. For further details and updates, stakeholders can visit the FDA’s official website and review the resources provided by the agency.
Read the guidance here.
Read the notice here.
