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.

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
• Supporting data as applicable
• Clinical data
• Non-Clinical Data
• Shelf Life
• Biocompatibility
• Sterilization
• Software
• Electrical safety
• Probable risks and benefits assessment

At Accorto, 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.