While regulatory bodies across the world consistently want to make sure that every device entering the market is safe and effective, never do they want to decelerate the pace at which new technologies are coming to the market. Along these lines is the FDA’s De Novo classification process which is used to classify medical devices that do not fall under the existing class of devices defined by the FDA. The De Novo classification process is also termed as ‘Evaluation of Automatic Class III Designation’.
As per Section 513(f)(1) of the FD&C Act, a new device that is not equivalent to an existing Class I or Class II device would automatically be classified as a Class III device irrespective of the associated risks or ability to demonstrate general or specific controls. This method of classification allows the review and approval of novel devices that could be safe and beneficial to end-users. The De Novo pathway supports the swift introduction of novel devices into the market, which would otherwise require a rigorous Pre-Market approval and review. Manufacturers can apply for a De Novo classification for low to moderate risk devices without submitting a 510 (k).
“For good ideas and true innovation, you need human interaction, conflict, argument, and debate.” – Margaret Heffernan
Most DeNovo today are preceded by the FDA pre-submission or EAP designation application, where the Manufacturer and FDA have an open transparent discussion or interaction on the new technology, testing conducted by Manufacturer, and the claims that are intended to be made; this has eased the arrival of innovation into the market facilitating focussed efforts of the Manufacturers that would result in an expedited regulatory approval.
In addition to what’s mentioned above, there are several eligibility criteria that one must revisit to ensure that DeNovo is indeed the right application to pursue.
In summary, if a device does not have any existing FDA classification, product code, or FDA cleared product to be used as a Predicate or received a 510(k) rejection (Non-Substantial Equivalence – NSE), it can most likely be eligible for a Denovo, given that it meets the requirements of Class I or II devices and the Manufacturer performed a thorough risk-benefit analysis which demonstrates the product to be low to moderate risk device.
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A successful DeNovo
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For a successful De Novo submission, the request should include:
- Administrative information and regulatory history
- Device description
- Classification summary information
- Device benefits and risks
- Performance data demonstrating a reasonable assurance of safety and efficacy
- Other information as prescribed by the FDA
Due diligence which is performed at Elexes to ensure all the DeNovo criteria are met and a thorough risk-benefit analysis which is well supported by data are the key elements to a successful DeNovo. Companies that work with us and take advantage of the provisions that the regulatory bodies have to propel innovation, consistently bring the inventions to patients