Regulatory Open Forum

Hi All,

I am currently a graduate student working toward an MSRA degree, and I have a question regarding the regulatory pathway for adding accessories intended for dental use to a medical device that has already been approved by the FDA. Are we required to demonstrate the safety and efficacy of these accessories, and is there a specific regulatory pathway for addressing this type of situation?

Appreciate your time and support.

Regards,

Rama 

Hi Rama

When you say "approved", is it safe to assume you mean the PMA pathway? If so, this guidance may help you think about whether the addition of the accessories changes things:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/modifications-devices-subject-premarket-approval-pma-pma-supplement-decision-making-process

Next question, are these new accessories, or are they already on the market and being used according to their intended use and indications? This guidance may help you think about accessory requirements:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways

Hi All,

I am currently a graduate student working toward an MSRA degree, and I have a question regarding the regulatory pathway for adding accessories intended for dental use to a medical device that has already been approved by the FDA. Are we required to demonstrate the safety and efficacy of these accessories, and is there a specific regulatory pathway for addressing this type of situation?

Appreciate your time and support.

Regards,

Rama 

Rama,

Accessories are treated differently in regions around the world, for some allowing to be regulated by themselves compared to others taking on the classification of whatever the accessory is attached.  Therefore, there may not be a separate regulatory pathway for getting on the market for some accessories depending on the region you are addressing.  In your case, talking about US FDA, medical device accessories may be regulated on their own if there is a separate Product Code and/or regulation, but in most cases the accessories are regulated the same as the parent device.  In fact, many of the regulation descriptions (can look at a few) include in the description accessories or components used with the 'X' device.  In all cases, it must be shown the accessory functions, operates, is used with the device, etc., in a way which does not compromise the safety or efficacy (performance) through compatibility testing, interfacing, connectivity, etc.

Hi Rama

When you say "approved", is it safe to assume you mean the PMA pathway? If so, this guidance may help you think about whether the addition of the accessories changes things:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/modifications-devices-subject-premarket-approval-pma-pma-supplement-decision-making-process

Next question, are these new accessories, or are they already on the market and being used according to their intended use and indications? This guidance may help you think about accessory requirements:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways

Hi All,

I am currently a graduate student working toward an MSRA degree, and I have a question regarding the regulatory pathway for adding accessories intended for dental use to a medical device that has already been approved by the FDA. Are we required to demonstrate the safety and efficacy of these accessories, and is there a specific regulatory pathway for addressing this type of situation?

Appreciate your time and support.

Regards,

Rama 

Hi Rama

When you say "approved", is it safe to assume you mean the PMA pathway? If so, this guidance may help you think about whether the addition of the accessories changes things:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/modifications-devices-subject-premarket-approval-pma-pma-supplement-decision-making-process

Next question, are these new accessories, or are they already on the market and being used according to their intended use and indications? This guidance may help you think about accessory requirements:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways

Hi All,

I am currently a graduate student working toward an MSRA degree, and I have a question regarding the regulatory pathway for adding accessories intended for dental use to a medical device that has already been approved by the FDA. Are we required to demonstrate the safety and efficacy of these accessories, and is there a specific regulatory pathway for addressing this type of situation?

Appreciate your time and support.

Regards,

Rama 

Hi All,

I am currently a graduate student working toward an MSRA degree, and I have a question regarding the regulatory pathway for adding accessories intended for dental use to a medical device that has already been approved by the FDA. Are we required to demonstrate the safety and efficacy of these accessories, and is there a specific regulatory pathway for addressing this type of situation?

Appreciate your time and support.

Regards,

Rama 

If the accessories are new add-ons to a product already on the market, they likely require a new submission to add them to the product. But you'd need to classify them, determine their intended use, etc. to confirm the need for a submission. If they change the intended use of the device they're used with, that would almost certainly require a submission.

The classification database is super helpful: https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database

Hi All,

I am currently a graduate student working toward an MSRA degree, and I have a question regarding the regulatory pathway for adding accessories intended for dental use to a medical device that has already been approved by the FDA. Are we required to demonstrate the safety and efficacy of these accessories, and is there a specific regulatory pathway for addressing this type of situation?

Appreciate your time and support.

Regards,

Rama 

Hi All,

I am currently a graduate student working toward an MSRA degree, and I have a question regarding the regulatory pathway for adding accessories intended for dental use to a medical device that has already been approved by the FDA. Are we required to demonstrate the safety and efficacy of these accessories, and is there a specific regulatory pathway for addressing this type of situation?

Appreciate your time and support.

Regards,

Rama 

Dear Rama,

If your comment includes the question that "is the dental device regulated differently than the other medical device", the answer is no. 

The dental device is regulated in the same way as the other category of medical device. 

If you mean that the accessory is adding the dental use as an intended use, this is a change in indications for use and requires a new submission I believe (I am not familiar with PMA but for 510(k), it shall be necessary). You can evaluate if a new 510(k) is necessary or not by this guidance. 

https://downloads.regulations.gov/FDA-2011-D-0453-0075/attachment_3.pdf

Hi All,

I am currently a graduate student working toward an MSRA degree, and I have a question regarding the regulatory pathway for adding accessories intended for dental use to a medical device that has already been approved by the FDA. Are we required to demonstrate the safety and efficacy of these accessories, and is there a specific regulatory pathway for addressing this type of situation?

Appreciate your time and support.

Regards,

Rama 

Hi All,

I am currently a graduate student working toward an MSRA degree, and I have a question regarding the regulatory pathway for adding accessories intended for dental use to a medical device that has already been approved by the FDA. Are we required to demonstrate the safety and efficacy of these accessories, and is there a specific regulatory pathway for addressing this type of situation?

Appreciate your time and support.

Regards,

Rama 

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Rama Doddi
Ms
Brighton MA
United States
------------------------------

Hello Rama and all involved in this discussion,

I want to express my appreciation for the valuable insights shared thus far. They have provided a solid foundation for comprehending the FDA's regulatory approach in the United States about medical device accessories.

To contribute to this discussion, it is necessary to clarify whether the dental accessory modifies the original "Indications for Use" or "Intended Use" of the already approved medical device. If it does, a new submission, such as a PMA Supplement or a 510(k) submission, may be required.

• PMA-approved devices: The inclusion of new accessories often requires a PMA Supplement. The type of supplement (180-day, Real-Time, or Special) is determined mainly by the level of risk attached to the accessory and the degree to which it could impact device safety and effectiveness.
• 510(k) cleared devices: Adding a new accessory may necessitate a new 510(k) submission if it alters the intended use or significantly affects the safety and efficacy of the device. The FDA's "Deciding When to Submit a 510(k) for a Change to an Existing Device" guidance can assist in determining the necessity of a new submission.

To ensure that the new accessory does not negatively impact the safety or effectiveness of the parent device, compatibility tests, risk assessments, and clinical evaluations may be necessary. It is also essential to consider any required labeling adjustments, including updated instructions for use (IFU).

Finally, the FDA has issued a guidance document on accessories and their classification pathways, which can provide additional clarity. You can find the document at Medical Device Accessories - Describing Accessories and Classification Pathways | FDA

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Kelvin Peek
Mr.
Rochester NY
United States

Original Message:
Sent: 11-Sep-2023 14:31
From: Rama Doddi
Subject: Is regulatory approval necessary for dental accessories to be used with a medical device that has already received approval? If it is required, what is the appropriate regulatory pathway to follow?

Hi All,

I am currently a graduate student working toward an MSRA degree, and I have a question regarding the regulatory pathway for adding accessories intended for dental use to a medical device that has already been approved by the FDA. Are we required to demonstrate the safety and efficacy of these accessories, and is there a specific regulatory pathway for addressing this type of situation?

Appreciate your time and support.

Regards,

Rama 

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Rama Doddi
Ms
Brighton MA
United States
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