Regulatory Open Forum

Hello Members,

I would like to understand if we have any Patient Implant Card or Leaflet requirement in the US for implantable devices like the way we have for EU MDR. Per my knowledge, we consider providing a card or sticker listing the basic information per the FDA Guidance on Medical Device
Patient Labeling issued in April 2001.

I just like to confirm my understanding here. Please let me know your thoughts here.

Thanks!

------------------------------
Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
------------------------------

Hi Shikha,

This may become an interesting conversation thread.
As a starter: are you talking about passive or active implants?

When it comes to implant testing and labeling, in recent years it has become good practice to ALWAYS consider the MRI safety aspects of such devices.

Suggested read: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", FDA Guidance published in 2021. Take into account all cited references.

One can argue that NO (implanted) device manufacturer is exempt from considering this guidance, as its scope reads "This guidance document applies to all medical devices that might be used in the MR environment. This includes all implanted medical devices, medical devices that are fastened to or carried by a patient (e.g., external insulin pump, pulse oximeter), medical devices that would reasonably be anticipated to enter the MR environment during clinical care, and all medical devices that are intended to enter the MR environment."
In that respect, FDA could be expected to be more advanced that EUMDR NBs - which will, hopefully, catch up soon.

Also, the horizontal ISO standard for passive implants suggests to consider MR Conditional aspects in design, testing and labeling.

Another relevant piece of information in this context is that IEC 60601-2-33 Edition 4 was published in August 2022.

It contains two important changes with respect to implants and MRI:
(1) the so-called 5 Gauss line has been changed to a 0.9 mT line (or 9 Gauss), based on extensive research and deliberation. We could not find any argument that fields lower than 1 mT would induce a safety risk in (active) devices or (non-medical) equipment.

(2) MROC is introduced as mandatory functionality for 1.5T and 3T systems. Once implemented, it will allow MR techs to ensure compliance with implant labels by a single controlling UI interaction at the start of the examination. As Philips person, I can direct you to our ScanWise Implant implementation, which is 'richer' than MROC in the sense that MROC does not require all modes to control MR outputs per historical (and still being released) implant labels, particularly so-called "fractional whole-body SAR".

------------------------------
Johan van den Brink
Principle Scientist & Architect
Best
Netherlands
------------------------------

Original Message:
Sent: 15-Sep-2022 16:50
From: Shikha Malik
Subject: US FDA Patient Implant Card or Leaflet requirement

Hello Members,

I would like to understand if we have any Patient Implant Card or Leaflet requirement in the US for implantable devices like the way we have for EU MDR. Per my knowledge, we consider providing a card or sticker listing the basic information per the FDA Guidance on Medical Device
Patient Labeling issued in April 2001.

I just like to confirm my understanding here. Please let me know your thoughts here.

Thanks!

------------------------------
Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
------------------------------

Hello Shikha,

While there is no specific regulation requiring an implant card similar to in Europe, Australia, or UK, there are individual references in product specific regulations.  As an example, 21 CFR 814 for PMA approvals talk about inclusion of identification codes kept 'on cards given to patients' if needed to protect the public health.  Companies which distribute implants around the world typically will create an implant card which can be used in all jurisdictions.  Also the recent guidance from FDA https://www.fda.gov/files/medical%20devices/published/Guidance-on-Medical-Device--Patient-Labeling---Final-Guidance-for-Industry-and-FDA-Staff.pdf on patient labelling make inference to information provided to user (and by extension patient or to the patient) based on the benefit/risk of the product.  So while not specifically required in the United States, it is becoming best practice based on other regulatory requirements.

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

Original Message:
Sent: 16-Sep-2022 02:29
From: Johan van den Brink
Subject: US FDA Patient Implant Card or Leaflet requirement

Hi Shikha,

This may become an interesting conversation thread.
As a starter: are you talking about passive or active implants?

When it comes to implant testing and labeling, in recent years it has become good practice to ALWAYS consider the MRI safety aspects of such devices.

Suggested read: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", FDA Guidance published in 2021. Take into account all cited references.

One can argue that NO (implanted) device manufacturer is exempt from considering this guidance, as its scope reads "This guidance document applies to all medical devices that might be used in the MR environment. This includes all implanted medical devices, medical devices that are fastened to or carried by a patient (e.g., external insulin pump, pulse oximeter), medical devices that would reasonably be anticipated to enter the MR environment during clinical care, and all medical devices that are intended to enter the MR environment."
In that respect, FDA could be expected to be more advanced that EUMDR NBs - which will, hopefully, catch up soon.

Also, the horizontal ISO standard for passive implants suggests to consider MR Conditional aspects in design, testing and labeling.

Another relevant piece of information in this context is that IEC 60601-2-33 Edition 4 was published in August 2022.

It contains two important changes with respect to implants and MRI:
(1) the so-called 5 Gauss line has been changed to a 0.9 mT line (or 9 Gauss), based on extensive research and deliberation. We could not find any argument that fields lower than 1 mT would induce a safety risk in (active) devices or (non-medical) equipment.

(2) MROC is introduced as mandatory functionality for 1.5T and 3T systems. Once implemented, it will allow MR techs to ensure compliance with implant labels by a single controlling UI interaction at the start of the examination. As Philips person, I can direct you to our ScanWise Implant implementation, which is 'richer' than MROC in the sense that MROC does not require all modes to control MR outputs per historical (and still being released) implant labels, particularly so-called "fractional whole-body SAR".

------------------------------
Johan van den Brink
Principle Scientist & Architect
Best
Netherlands

Original Message:
Sent: 15-Sep-2022 16:50
From: Shikha Malik
Subject: US FDA Patient Implant Card or Leaflet requirement

Hello Members,

I would like to understand if we have any Patient Implant Card or Leaflet requirement in the US for implantable devices like the way we have for EU MDR. Per my knowledge, we consider providing a card or sticker listing the basic information per the FDA Guidance on Medical Device
Patient Labeling issued in April 2001.

I just like to confirm my understanding here. Please let me know your thoughts here.

Thanks!

------------------------------
Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
------------------------------