Hi friends!!!
In our previous blogs, we have discussed about the following topics.
US FDA Premarket Notification 510(k)
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
EU MDR Technical Documentation - Part 1
EU MDR Technical Documentation - Part 2
EU MDR General Safety and Performance Requirement
EU MDR Information on the Label
EU MDR Post Market Clinical Follow Up
EU MDR Unique Device Identification - Part 1
EU MDR Unique Device Identification - Part 2
EU MDR Chapter & Articles - Part 1
EU MDR Chapter & Articles - Part 2
EU MDR Procedure for Custom-Made Devices
EU MDR Certificates Issued by Notified Body
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.
Check out for this blog about Computed Tomography, X ray, MRI scan, ECG.
COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS
x ray machine working principle
Check out for the below blogs about IEC 62304 & IEC 60601-1.
IEC 62304 Software Configuration Management & Problem Resolution Process
IEC 62304 Software Maintenance Process
IEC 62304 Software System Testing
IEC 62304 Software Unit Implementation & Integration
IEC 62304 Software Architectural & Detailed Design
IEC 62304 Software Requirements Analysis
IEC 62304 Software Development Planning
IEC 62304 Overview & Definitions
IEC 60601-1 Classification of Medical Electrical Equipment
IEC 60601-1 General Requirements for Testing Medical Electrical Equipment
IEC 60601-1 Medical Electrical Systems
IEC 60601-1 Protection against unwanted and excessive radiation hazards
IEC 60601-1 General Requirements
IEC 60601-1 Programmable Electrical Medical Systems
IEC 60601-1 Hazardous situations and fault condition
