Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

It appears that a 513(g) is not really used to get a device classification from the FDA.  Please advise if I'm correct. 

What is the main reason to use 513(g) vs. De Novo?

Is De Novo the only way to find out the possible classification if there is nothing that is a substantial equivalent?  

In addition, how hard is it to request a meeting with the FDA for further discussion if needed?

Thank you!

Hello Anon,

The 513(g) Request for Classification is the proper method to determine if a device falls into a Product Code or Regulation.  If you already know there is not Product Code or Regulation and so by default no predicate device, then you could proceed straight to De Novo.  While this can be done, going through 513(g) and/or Q-Submission allows the Agency to see your device before the actual submission itself.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 27-Jun-2023 09:59
From: Anonymous Member
Subject: 513(g) - Device Classification

This message was posted by a user wishing to remain anonymous

It appears that a 513(g) is not really used to get a device classification from the FDA.  Please advise if I'm correct. 

What is the main reason to use 513(g) vs. De Novo?

Is De Novo the only way to find out the possible classification if there is nothing that is a substantial equivalent?  

In addition, how hard is it to request a meeting with the FDA for further discussion if needed?

Thank you!

This message was posted by a user wishing to remain anonymous

Thank you!  I appreciate your valued feedback.  It validates my anticipated strategy.

Original Message:
Sent: 28-Jun-2023 08:52
From: Richard Vincins
Subject: 513(g) - Device Classification

Hello Anon,

The 513(g) Request for Classification is the proper method to determine if a device falls into a Product Code or Regulation.  If you already know there is not Product Code or Regulation and so by default no predicate device, then you could proceed straight to De Novo.  While this can be done, going through 513(g) and/or Q-Submission allows the Agency to see your device before the actual submission itself.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 27-Jun-2023 09:59
From: Anonymous Member
Subject: 513(g) - Device Classification

This message was posted by a user wishing to remain anonymous

It appears that a 513(g) is not really used to get a device classification from the FDA.  Please advise if I'm correct. 

What is the main reason to use 513(g) vs. De Novo?

Is De Novo the only way to find out the possible classification if there is nothing that is a substantial equivalent?  

In addition, how hard is it to request a meeting with the FDA for further discussion if needed?

Thank you!

This message was posted by a user wishing to remain anonymous

Hello. I use a 513(g) mailbox to clarify the classification of device accessories or software functions. It is really valuable to save time and effort to discuss internally.  

Please see ChatGTP's opinion below. I agree with ChatGPT. 

Here are a few key points about the value of a 513(g) submission:

1.           Clarification of Device Classification: One of the primary purposes of a 513(g) submission is to seek FDA's input on the appropriate classification of a medical device. The FDA assigns devices to different classes (Class I, II, or III) based on the level of risk they pose to patients and users. Understanding the correct classification is crucial as it determines the regulatory pathway and requirements for marketing the device.

2.           Regulatory Guidance: By submitting a 513(g) request, manufacturers can receive valuable guidance from the FDA on the regulatory requirements applicable to their device. This feedback can include information on applicable regulations, standards, premarket submissions (such as 510(k) or Premarket Approval), and any special controls or labeling requirements.

3.           Risk Mitigation: The FDA's feedback through the 513(g) submission can help manufacturers identify potential risks associated with their medical device and develop appropriate strategies to mitigate those risks. It allows manufacturers to address regulatory concerns proactively, potentially avoiding delays or obstacles during the regulatory review process.

4.           Product Development and Planning: Obtaining FDA input early in the development process through a 513(g) submission can help manufacturers plan their product development and regulatory strategies effectively. The feedback received can assist in making informed decisions about design modifications, clinical study requirements, and overall development timelines.

5.           Increased Confidence: By engaging with the FDA through the 513(g) process, manufacturers gain a better understanding of the regulatory landscape and expectations. This interaction enhances confidence in the regulatory compliance of their medical device and can also provide reassurance to potential investors, partners, and stakeholders.

It's important to note that while a 513(g) submission provides valuable regulatory guidance and feedback, it is not a formal approval or clearance process. It is an informational request that helps manufacturers navigate the regulatory pathway for their device.

Original Message:
Sent: 27-Jun-2023 09:59
From: Anonymous Member
Subject: 513(g) - Device Classification

This message was posted by a user wishing to remain anonymous

It appears that a 513(g) is not really used to get a device classification from the FDA.  Please advise if I'm correct. 

What is the main reason to use 513(g) vs. De Novo?

Is De Novo the only way to find out the possible classification if there is nothing that is a substantial equivalent?  

In addition, how hard is it to request a meeting with the FDA for further discussion if needed?

Thank you!

Hello Anon, 

Section 513(g) of the FD&C acts is meant for manufacturers to obtain information about the FDA's views regarding the classification of a device. You could get following information from the FDA:

•           Class of device within that generic type,
•           PMA, 510(k) or neither is required in order to market device, 
•           Other requirements applicable to device of the particular class,
•           Whether additional FDA requirements may apply, and so forth..

Refer to this guidance for more information: ://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/media/78456/download 

De novo is an application to market a new product that does not have a predicate to go through the 510K route. Recommend doing a pre-submission when going this path. There are many links on the FDA site regarding both these topics. 

------------------------------
Suraj Maharjan
Sr. Regulatory Affairs Specialist
Windham NH
United States
------------------------------

Original Message:
Sent: 27-Jun-2023 09:59
From: Anonymous Member
Subject: 513(g) - Device Classification

This message was posted by a user wishing to remain anonymous

It appears that a 513(g) is not really used to get a device classification from the FDA.  Please advise if I'm correct. 

What is the main reason to use 513(g) vs. De Novo?

Is De Novo the only way to find out the possible classification if there is nothing that is a substantial equivalent?  

In addition, how hard is it to request a meeting with the FDA for further discussion if needed?

Thank you!

This message was posted by a user wishing to remain anonymous

Thank you!

Original Message:
Sent: 28-Jun-2023 09:06
From: Suraj Maharjan
Subject: 513(g) - Device Classification

Hello Anon, 

Section 513(g) of the FD&C acts is meant for manufacturers to obtain information about the FDA's views regarding the classification of a device. You could get following information from the FDA:

•           Class of device within that generic type,
•           PMA, 510(k) or neither is required in order to market device, 
•           Other requirements applicable to device of the particular class,
•           Whether additional FDA requirements may apply, and so forth..

Refer to this guidance for more information: ://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/media/78456/download 

De novo is an application to market a new product that does not have a predicate to go through the 510K route. Recommend doing a pre-submission when going this path. There are many links on the FDA site regarding both these topics. 

------------------------------
Suraj Maharjan
Sr. Regulatory Affairs Specialist
Windham NH
United States

Original Message:
Sent: 27-Jun-2023 09:59
From: Anonymous Member
Subject: 513(g) - Device Classification

This message was posted by a user wishing to remain anonymous

It appears that a 513(g) is not really used to get a device classification from the FDA.  Please advise if I'm correct. 

What is the main reason to use 513(g) vs. De Novo?

Is De Novo the only way to find out the possible classification if there is nothing that is a substantial equivalent?  

In addition, how hard is it to request a meeting with the FDA for further discussion if needed?

Thank you!

You are correct about the purpose of a 513(g) request.

A section 513(g) Request for Information is not for getting an official classification of the subject device.  A 513(g) is officially designated as a "Request for Information", not a request for classification.  Yet it can certainly be insightful for knowing what FDA anticipates the classification to be.  FDA's response to a 513(g) request is not an official device classification decision. Instead, a 513(g) Request for Information is for obtaining FDA's unofficial nonbinding opinion about the apparent classification and basic regulatory requirements that may be applicable to the proposed subject device.

Ultimately, the official initial official classification of a proposed subject device not eligible for Class I/II 510(k)-exemption generally happens via the 510(k) process, or the 513(f)(2) ("De Novo Classification") process, or, if the aforesaid routes aren't applicable, then automatically via the Class III PMA process.

If it is certain that there is definitely no legally marketed predicate device nor existing classification regulation, then I tend to boil the approach down to two key tactics:

• If, based on proper risk analysis and benefit-risk considerations, I believe that the proposed subject device is a good candidate for the intrinsic attributes and parameters of FDA Class I or II, then I generally think about the De Novo Classification process.

• But if instead the risk profile of the proposed subject device meets FDA's criteria for Class III, then, by law, that automatically pushes the pathway toward the PMA route.

For your question, "How hard is it to request a meeting with the FDA for further discussion if needed?"  In short, such further discussion would generally need to happen via one of two ways:

• A supplemental 513(g) Request for Information (and supplemental user fee) because you've added a new classification question to the discussion, or

• If FDA feels that its prior answers to your 513(g) request(s) have already adequately informed you and the agency about the projected classification status and basic regulatory requirements of the subject device, then via a Q-Sub.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 27-Jun-2023 09:59
From: Anonymous Member
Subject: 513(g) - Device Classification

This message was posted by a user wishing to remain anonymous

It appears that a 513(g) is not really used to get a device classification from the FDA.  Please advise if I'm correct. 

What is the main reason to use 513(g) vs. De Novo?

Is De Novo the only way to find out the possible classification if there is nothing that is a substantial equivalent?  

In addition, how hard is it to request a meeting with the FDA for further discussion if needed?

Thank you!

This message was posted by a user wishing to remain anonymous

Thank you, Kevin.  This is very helpful!

Original Message:
Sent: 28-Jun-2023 11:38
From: Kevin Randall
Subject: 513(g) - Device Classification

You are correct about the purpose of a 513(g) request.

A section 513(g) Request for Information is not for getting an official classification of the subject device.  A 513(g) is officially designated as a "Request for Information", not a request for classification.  Yet it can certainly be insightful for knowing what FDA anticipates the classification to be.  FDA's response to a 513(g) request is not an official device classification decision. Instead, a 513(g) Request for Information is for obtaining FDA's unofficial nonbinding opinion about the apparent classification and basic regulatory requirements that may be applicable to the proposed subject device.

Ultimately, the official initial official classification of a proposed subject device not eligible for Class I/II 510(k)-exemption generally happens via the 510(k) process, or the 513(f)(2) ("De Novo Classification") process, or, if the aforesaid routes aren't applicable, then automatically via the Class III PMA process.

If it is certain that there is definitely no legally marketed predicate device nor existing classification regulation, then I tend to boil the approach down to two key tactics:

• If, based on proper risk analysis and benefit-risk considerations, I believe that the proposed subject device is a good candidate for the intrinsic attributes and parameters of FDA Class I or II, then I generally think about the De Novo Classification process.

• But if instead the risk profile of the proposed subject device meets FDA's criteria for Class III, then, by law, that automatically pushes the pathway toward the PMA route.

For your question, "How hard is it to request a meeting with the FDA for further discussion if needed?"  In short, such further discussion would generally need to happen via one of two ways:

• A supplemental 513(g) Request for Information (and supplemental user fee) because you've added a new classification question to the discussion, or

• If FDA feels that its prior answers to your 513(g) request(s) have already adequately informed you and the agency about the projected classification status and basic regulatory requirements of the subject device, then via a Q-Sub.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 27-Jun-2023 09:59
From: Anonymous Member
Subject: 513(g) - Device Classification

This message was posted by a user wishing to remain anonymous

It appears that a 513(g) is not really used to get a device classification from the FDA.  Please advise if I'm correct. 

What is the main reason to use 513(g) vs. De Novo?

Is De Novo the only way to find out the possible classification if there is nothing that is a substantial equivalent?  

In addition, how hard is it to request a meeting with the FDA for further discussion if needed?

Thank you!