De Novo Classification Request for Medical Devices

As mentioned in OnemataDC’s U.S. Medical Device Regulations article, low and moderate risk medical devices may require a De Novo Classification Request if there is no predicate or similar established device.  Per the FDA, De Novo classification is a risk-based classification process that “provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use.”

Since the FDA offers two options to submit a De Novo request to the FDA to determine the risk-based classification of a medical device into either Class I or Class II, it’s best to find a partner that can help determine the best path forward.  And often, a pre-submission is advisable for the best outcome regarding the FDA’s ultimate decision about the medical device.

FDA authorization of a new device hinges on proven general and special controls to demonstrate its risk and classification.  Thus, aligning with an experienced partner that can help analyze and improve your controls will help drive an efficient interaction with the FDA and ultimately a successful De Novo submission.  OnemataDC’s team is experienced with De Novo Classification Requests and can help your organization establish the best path forward.

Reach out to speak with OnemataDC’s team today!