Saturday, March 29, 2025

US FDA De Novo Submission

Hi friends!!!


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


US FDA Premarket Notification 510(k)


EU MDR Assessment Routes


EU MDR Timeline, Annex, Chapter


EU MDR Post Market Surveillance


EU MDR Clinical Evaluation


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 Classification Rules


EU MDR EUDAMED


EU MDR Economic Operators


EU MDR Chapter & Articles - Part 1


EU MDR Chapter & Articles - Part 2


EU MDR Clinical Investigation


EU MDR Scrutiny Procedure


EU MDR Instructions for Use


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.

 

Image courtesy: Wikipedia
Licensed under: CC Share Alike


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.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


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 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

 

 

Sunday, December 29, 2024

US FDA Premarket Notification 510(k)

Hi friends!!!


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


EU MDR Assessment Routes


EU MDR Timeline, Annex, Chapter


EU MDR Post Market Surveillance


EU MDR Clinical Evaluation


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 Classification Rules


EU MDR EUDAMED


EU MDR Economic Operators


EU MDR Chapter & Articles - Part 1


EU MDR Chapter & Articles - Part 2


EU MDR Clinical Investigation


EU MDR Scrutiny Procedure


EU MDR Instructions for Use


EU MDR Procedure for Custom-Made Devices


EU MDR Certificates Issued by Notified Body


In today's blog, we will explore about 510(k) submission, its requirements, its importance of demonstrating substantial equivalence & how it impacts the medical device industry.  Whether you're a startup or established manufacturer, understanding the 510(k) 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 510(k). 

Let's get into the topic.


Premarket Notification 510(k) 

Every domestic manufacturer, specification developers, foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters trying to market their device in US shall submit 510(k). This will also be applicable for repackers or relabelers who make labeling changes or whose operations significantly affect the device. Therefore, it is very important for above mentioned stakeholders to know in detail about 510(k) submission.


Image courtesy: Wikipedia
Licensed under: CC Share Alike

What is Premarket Notification 510 (k)?

A 510(k) is a premarket submission made to FDA which requires you to demonstrate that your medical device is substantially equal to the another legally US marketed device. Substantial equivalence shall be demonstrated by proving that your medical device is as safe and effective as the predicate device.

The term “Predicate” is used to represent the medical device(s) legally marketed in US, to which equivalence is drawn during the 510(k) submission.

The question of your medical device’s substantial equivalence shall be based on the following criteria:

The first criteria to claim substantial equivalency to the predicate medical device is that your device has same intended use as compared to the predicate medical device and it has the same technological characteristics as compared to the predicate medical device.

The second criteria to claim substantial equivalency to the predicate medical device is that your device has same intended use as compared to the predicate medical device and even if your device has a different technological characteristic, it shall not raise different questions related to the safety and effectiveness and the information submitted to FDA shall demonstrate that your device is as safe and effective as the legally marketed predicate medical device.


Product Codes:

The Product codes are Three letter codes used by FDA to identify and track similar medical devices

The Product codes are used by 510(k) submitters to search for a predicate device(s) to prove substantial equivalence. The Product codes can be found on most of the 510(k) clearance letters.


Types of 510(k) Submission:

Traditional 510(k)

The Traditional 510(k) relies on demonstrating substantial equivalence. The Traditional 510(k) can be used under any circumstances.

Abbreviated 510(k)

The Abbreviated 510(k) relies on the use of recognized standards, special controls and guidance documents. Under certain conditions, the submitter or sponsor shall not need to submit the test data.

Special 510(k)

The Special 510(k) shall be submitted in case of modifications to manufacturers own legally marketed device. Data is not evaluated by FDA.


The following are the questions that needs to be answered to attain eligibility for Special 510(k) Submission:

Is there any change to the manufacturer’s own legally marketed medical device?

Are performance data needed to evaluate the change?

Are there any methods which are well-established to evaluate the change?

Can the medical devices data be reviewed in a summary or risk analysis format?

If answers to all the above questions falls under Yes category, then your modifications to the device shall be reviewed as Special 510(k).

 

Contents of 510(k) Submission:

The following are the important information that needs to be submitted during 510(k), but are not limited to:

Indications for use.

510(k) Summary.

Declaration of conformity & guidance documents.

Device Description.

Substantial Equivalence Discussion.

Proposed Labelling.

Performance Testing – Bench.

Performance Testing – Animal.

Performance Testing – Clinical.


Now I hope you have acquired some basic knowledge about the requirements of 510(k). 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.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


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 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


 

Wednesday, July 31, 2024

EU MDR Certificates issued by Notified Body

Hi friends!!!


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


EU MDR Assessment Routes


EU MDR Timeline, Annex, Chapter


EU MDR Post Market Surveillance


EU MDR Clinical Evaluation


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 Classification Rules


EU MDR EUDAMED


EU MDR Economic Operators


EU MDR Chapter & Articles - Part 1


EU MDR Chapter & Articles - Part 2


EU MDR Clinical Investigation


EU MDR Scrutiny Procedure


EU MDR Instructions for Use


EU MDR Procedure for Custom-Made Devices


EU MDR 2017/745 is live now. And it is the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe. 


Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745. In today's blog, we are going to discuss about the requirements of Certificates issued by a Notified Body as per EU MDR 2017/745. 


Let's get into the topic.


Certificates issued by a Notified Body:

In EU MDR 2017/745, Annex XII provides the requirements for Certificates issued by a notified body.


General Requirements:

The following are the general requirements for the Certificates issued by a notified body.

 

The Certificates issued by a Notified Body shall be in one of the official languages of Union. And each Certificate shall only be issued to one medical device manufacturer.

Only one Conformity Assessment Procedure shall be referred in the Certificate.

The name and address of the medical device manufacturer provided in the certificate shall match with the details registered in electronic system in accordance with article 30 of EU MDR 2017/745.

The device or devices covered in the scope of the certificates shall be unambiguously identified.

EU Technical Documentation assessment certificates, EU Type Examination certificates and EU Product Verification certificates shall include the clear identification of the name, model & type of the medical device or devices, intended purpose as identified in the IFU by the manufacturer, risk classification, basic UDI-DI in accordance with Article 27(6) of EU MDR 2017/745.

EU Quality Management System certificates and EU Quality Assurance certificates shall include the identification of the medical device or devices, risk classification. In case of Class IIb devices, the intended purpose shall also be included.

On request, the notified body shall be able to identify, which devices are covered by the certificate. The notified body shall also set up a system that enables the determination of the medical devices and their classification covered by the certificate.

When a certificate is supplemented, modified or re-issued, the new certificate shall contain a reference to the preceding certificate and information about its date of issue along with the identification of changes.


Minimum Content of the Certificates:

The following are the minimum contents needed in the Certificates issued by a notified body.

 

The name, address and identification number of the notified body issuing the certificate.

The name and address of the manufacturer of the medical device. If applicable, the name and address of the authorized representative shall also be provided.

The Unique number for identifying the certificate. And the date of issue & expiry.

Data needed for the unambiguous identification of the device or devices as specified in above general requirements.

The SRN of the manufacturer of medical device, if already issued.

Reference to any previous certificates as described in above general requirements, if applicable.

Reference to EU MDR regulation and relevant annex by which the conformity assessment has been carried out shall be provided in the certificate.

Reference to parts of technical documentation or other certificates shall be provided in the certificate, if applicable.

Reference to examinations and tests performed shall be provided in the certificates. For example, Reference to relevant harmonized standards, test reports & audit reports etc.

The legally binding signature of the notified body issuing the certificates shall provided in accordance with the national law.

If applicable, the information about the surveillance by the notified body shall also be provided in the certificate.

 

Now I hope you have acquired some basic knowledge about the requirements of Certificates issued by a Notified Body as per EU MDR 2017/745. We will meet again with another valuable topic related to 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.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


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 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