The De Novo pathway is an important regulatory route for novel, low-to-moderate risk medical devices that have no legally marketed predicate device. Understanding when and how to use the De Novo pathway can be crucial for getting your innovative device to market.
What is the De Novo Pathway?
The De Novo pathway was established to provide a pathway for devices that are novel and for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness. Unlike the traditional 510(k), a De Novo request establishes a new device type and classification.
When to Use De Novo
De Novo is appropriate when:
- Your device is novel with no appropriate predicate
- Your device would be classified as Class III by default under the FD&C Act
- General and/or special controls can provide reasonable assurance of safety and effectiveness
Preparing Your De Novo Request
A complete De Novo request includes detailed information about the device, proposed classification, proposed special controls, and comprehensive performance testing data. Our team at Sequence Group can help you prepare a thorough and compelling De Novo submission.
Contact Us
If you believe your device may qualify for the De Novo pathway, contact Sequence Group today for a free consultation. Our regulatory experts will evaluate your situation and help determine the best regulatory strategy for your device.
Frequently Asked Questions
What is the De Novo pathway and how does it differ from a traditional 510(k)?
The De Novo pathway is a regulatory classification process for novel, low-to-moderate risk devices that have no legally marketed predicate device. Unlike a traditional 510(k), which demonstrates substantial equivalence to a predicate, a De Novo request establishes a new device type and classification under Class I or Class II. The resulting De Novo order then becomes the basis for future 510(k) submissions from other manufacturers of substantially equivalent devices in the same category.
When is the De Novo pathway the right regulatory strategy for a device?
De Novo is appropriate in three situations: the device is novel with no appropriate legally marketed predicate device; the device would be classified as Class III by default under the FD&C Act because no predicate exists and no classification regulation covers the device type; and general controls alone, or general and special controls together, can provide reasonable assurance of safety and effectiveness. If a device fits within an existing Class I or Class II classification regulation with a suitable predicate, a 510(k) is the more direct pathway.
What information must be included in a De Novo request?
A complete De Novo request includes detailed information about the device and its intended use, the proposed device type name and classification recommendation (Class I or Class II), proposed special controls with supporting rationale explaining why they provide reasonable assurance of safety and effectiveness, and comprehensive performance testing data supporting the classification recommendation. The FDA may request additional information during review, making thorough upfront preparation and early engagement through a pre-submission meeting important for an efficient review.