What Is a De Novo Classification Request?
A De Novo Classification Request, or 513(a)(1), is a formal request to the US Food and Drug Administration (FDA) to classify a novel medical device for which general controls provide reasonable assurance for the medical device’s safety and effectiveness in the device’s intended use, but for which there is no substantially equivalent (SE) medical device currently being legally marketed in the United States. This request is provided to the agency along with a packet including administrative documents and forms, along with all relevant data and testing proving the safety and efficacy of the device. As there is no substantial equivalent to this device currently on the market, applicants under this pathway will need to provide significantly more data and documentation proving the product’s safety and efficacy than would be required under an SE pathway.
A device that is classified as a class I or class II device through a De Novo classification request can then be marketed and used as a predicate device for future 510(k) submissions when applicable.
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What is Included in a De Novo Classification Request:
De Novo Classification Requests contain hundreds to thousands of individual documents and data reports, with specific required studies and testing ranging based on the device’s intended use and risk level.
In general, De Novo requests include:
- Cover Sheet
- Administrative information and documentation
- Device description
- Proposed Classification information
- Probable risks and benefits assessment
- Cover Sheet
- Administrative information and documentation
- Device description
- Proposed Classification information
- Probable risks and benefits assessment
- Supporting data as applicable, including:
- Clinical data
- Non-Clinical Data
- Shelf Life
- Biocompatibility
- Sterilization
- Software
- Electrical safety
- Supporting data as applicable, including:
- Clinical data
- Non-Clinical Data
- Shelf Life
- Biocompatibility
- Sterilization
- Software
- Electrical safety
How Accorto Can Help
Our in-house team of regulatory specialists, along with our network of some of the world’s leading CRO’s and industry experts, are ready and able to handle your De Novo Classification Request from start to finish and anywhere in-between. Contact our team today to learn how we can bring your novel medical device to market quickly and efficiently.
Industry Experts
Backed by a collective experience of over 150 years with the FDA across a range of regulated sectors, our team brings an unparalleled depth of knowledge and expertise to your De Novo submission.
Custom Tailored Solutions
We recognize the unique needs of each of our clients, which is why we customize our approaches to fit your budget and timeline. Our personalized strategies ensure you receive top-tier regulatory services without compromising on your specific goals and resources.
Accelerate Your To-Market Timeline
We understand time to market can critically impact market success for our clients. With our streamlined processes, you’ll experience a faster journey from submission to approval.
Contact Us
to discuss how Accorto can help you achieve market authorization for
your product through the De Novo pathway today.
