De Novo Classification

by Sarah Koehler | Jun 27, 2022 | 510k, Audits, Blog, Certificates, Classification, Compliance, Consulting Group, De Novo, Documents, Engineering, FDA, Guidance, Human Factors, Inspections, Medical Devices, Pharmaceuticals, Product Development, QMS, Quality, Quality Systems, Regulatory, Requirements, Risk Management, Safety, Standardization, Standards, Tools, Validation, Verification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device¹. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.

The device classification is determined through a Food and Drug Administration (FDA) risk-based evaluation for the device. The two-evaluation classification utilized are as follows:

Option 1: After receiving a high-level not substantially equivalent (NSE) determination in response to a 510(k) submission.
Option 2: Upon the requester’s determination that there is no legally marketed device upon which to base a determination of substantial equivalence¹.

For option one there is no predicate device, a new intended use, or different technological characteristics than any marketed device which raised a question about the device’s safety and effectiveness. If the device falls into option two, a 510K was not submitted for the device, or a high-level substantially equivalent determination was not received. It is recommended by the FDA guidance to submit a pre-submission for the device to ensure the appropriate pathway is followed.

When submitting a De Novo request, ensure the aspects needed for acceptance of the request are provided. The FDA can deny any submission that does not include all the requirements such as a cover sheet, administrative information, device description and classification information, and supporting data.

Ensure your FDA De Novo Submission method includes a provided signed receipt of submission and or delivery. After a device is approved and classified through the De Novo Pathway it can be marketed and used as a predicate for future premarket submissions. If your company needs assistance with a De Novo submission or any other medical device submission type, EMMA International is here to help. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.

¹FDA (January 2022) De Novo Classification Request, retrieved on June 26, 2022, from https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request#What_is_a_De_Novo_Classification_Request_

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.