Hi friends!!!

In our previous blogs, we have discussed about the following topics.

In today’s blog, we will explore about De Novo submission & its requirements. Whether you’re a startup or established manufacturer, understanding the De Novo submission is vital for ensuring regulatory compliance and bringing your product to the market

It is also important for Medical Device QA/RA Professionals to know in detail about De Novo submission.

Let’s get into the topic.

What is De Novo Request?

The De Novo request is a type of marketing pathway for classifying novel medical devices having general controls alone, or general and special controls (Low to Moderate risk devices) which provides a reasonable assurance of safety and effectiveness for the intended use, but there is not legally marketed predicate device for these kinds of novel medical devices.

The De Novo is also Intended for devices that are automatically classified into class III by virtue of not yet being classified. These devices shall satisfy the below classification process to get classified as Class I or Class II under De Novo request.

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What is the Classification Process?

The De Novo classification is a risk-based classification approach:

Determine if the probable benefit of using your device outweighs the probable risks associated.

Probable risks to health by using the device or product shall be determined.

Level of regulatory controls needed for the device shall be determined.

Once all the above mentioned are determined, the following condition shall be considered:

If only general controls are used for mitigating the risk, then the device is Class I.

If general controls + special controls are used for mitigating the risk, then the device is Class II.

When to submit for a De Novo Request?

Scenario 1: If your medical device receives a not substantially equivalent (NSE) result during a 510(k) submission (It means, your medical device does not have any predicate device, it has new intended use or different technological characteristics which raises a different question related to safety and effectiveness).

Scenario II: The Submitter or requester can determine that there is no legally marketed medical device upon which a substantial equivalence can be proved. (Before even submitting the 510(k) and receiving high level NSE).

What does the regulation say?

In general, 21 CFR 860 provides the bases for Medical Device Classification procedures. The 21 CFR 860 Subpart D states the requirement for De Novo submission. The following are the requirements:

860.200: Purpose and applicability.

860.210: De Novo request format.

860.220: De Novo request content.

860.230: Accepting a De Novo request.

860.240: Procedures for review of a De Novo request.

860.250: Withdrawal of a De Novo request.

860.260: Granting or declining a De Novo request.

Contents of De Novo request:

The following are the important information specific to De Novo request that needs to be submitted, but are not limited to:

Administrative Information (Eg: Applicant name, contact name, address & contact information)

Regulatory History (Previously submitted 510k and NSE decisions, IDE’s, pre-submission information, previously granted or declined De Novo details)

Device information and summary (Device name and description, intended use, indications for use, technological characteristics)

Classification summary

Summary of risks and mitigations

Summary of known/potential risk to health

Proposed special controls

Classification recommendation

Summary of studies (Eg: Pre-clinical, animal, clinical)

Benefit and risk considerations

Device labelling

Other information reasonably known to the requester

Other information to support reasonable assurance of safety and effectiveness

What happens if De Novo is granted?

Once De Novo is granted, the FDA establishes a new device type along with the classification regulation for the device, necessary controls and product code.

The De Novo granted device shall be considered as a first predicate device for its kind.

Now I hope you have acquired some basic knowledge about the requirements of De Novo submission. We will meet again with another valuable topic related to MedTech Quality & Regulatory, Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!… Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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