Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all, 
as part of our device we have a tablet provided by a European supplier. As such the tablet is CE marked (including RoHS, EMC, etc).
Which other certificates we need to collect if we want to sell the tablet as part of our medical device in USA?
Thanks

In the US, a CE mark is not relevant.

Assuming you've already defined requirements and verified the specifications match -- compatibility with the necessary cleaning and disinfectants, cybersecurity, networking, wireless communication, camera or no camera, microphone or no microphone, UL/ETL listing, etc.

If this tablet has a lithium battery, you'll need to collect the test summary. (See the IATA guidance for some explanation.)

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 11-Sep-2020 12:14
From: Anonymous Member
Subject: tablet to be distributed in USA as part of a medical device

This message was posted by a user wishing to remain anonymous

Hi all,
as part of our device we have a tablet provided by a European supplier. As such the tablet is CE marked (including RoHS, EMC, etc).
Which other certificates we need to collect if we want to sell the tablet as part of our medical device in USA?
Thanks

Also, need to consider Wireless coexistence, Wireless coexistence risk analysis, RFID testing that FDA is really pushing for most submissions now and has been added into IEC 60601-1-2, ed. 4.1 which was added into the standard by the FDA (recently published and FDA plans on Recognizing this standard in Fall of this year probably with a 3 year transition period.).

Also, standards to consider are at least 60601-1, 60601-1-2, 60601-1-6, 60601-1-8 (Alarm Systems?), 60601-1-11 (Home Health Care - if applicable to your product), 62304 (software lifecycle process), 62366-1 (usability), 14971:2019, etc....

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 19-Sep-2020 18:49
From: Anne LeBlanc
Subject: tablet to be distributed in USA as part of a medical device

In the US, a CE mark is not relevant.

Assuming you've already defined requirements and verified the specifications match -- compatibility with the necessary cleaning and disinfectants, cybersecurity, networking, wireless communication, camera or no camera, microphone or no microphone, UL/ETL listing, etc.

If this tablet has a lithium battery, you'll need to collect the test summary. (See the IATA guidance for some explanation.)

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 11-Sep-2020 12:14
From: Anonymous Member
Subject: tablet to be distributed in USA as part of a medical device

This message was posted by a user wishing to remain anonymous

Hi all,
as part of our device we have a tablet provided by a European supplier. As such the tablet is CE marked (including RoHS, EMC, etc).
Which other certificates we need to collect if we want to sell the tablet as part of our medical device in USA?
Thanks

Anne and Leo, would you recommend the same if the software were a SaMD and the company supplied customers an android phone with the SaMD installed as an app?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Sep-2020 02:13
From: Leonard Eisner
Subject: tablet to be distributed in USA as part of a medical device

Also, need to consider Wireless coexistence, Wireless coexistence risk analysis, RFID testing that FDA is really pushing for most submissions now and has been added into IEC 60601-1-2, ed. 4.1 which was added into the standard by the FDA (recently published and FDA plans on Recognizing this standard in Fall of this year probably with a 3 year transition period.).

Also, standards to consider are at least 60601-1, 60601-1-2, 60601-1-6, 60601-1-8 (Alarm Systems?), 60601-1-11 (Home Health Care - if applicable to your product), 62304 (software lifecycle process), 62366-1 (usability), 14971:2019, etc....

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 19-Sep-2020 18:49
From: Anne LeBlanc
Subject: tablet to be distributed in USA as part of a medical device

In the US, a CE mark is not relevant.

Assuming you've already defined requirements and verified the specifications match -- compatibility with the necessary cleaning and disinfectants, cybersecurity, networking, wireless communication, camera or no camera, microphone or no microphone, UL/ETL listing, etc.

If this tablet has a lithium battery, you'll need to collect the test summary. (See the IATA guidance for some explanation.)

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 11-Sep-2020 12:14
From: Anonymous Member
Subject: tablet to be distributed in USA as part of a medical device

This message was posted by a user wishing to remain anonymous

Hi all,
as part of our device we have a tablet provided by a European supplier. As such the tablet is CE marked (including RoHS, EMC, etc).
Which other certificates we need to collect if we want to sell the tablet as part of our medical device in USA?
Thanks

In what sense is it part of your medical device?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 11-Sep-2020 12:14
From: Anonymous Member
Subject: tablet to be distributed in USA as part of a medical device

This message was posted by a user wishing to remain anonymous

Hi all,
as part of our device we have a tablet provided by a European supplier. As such the tablet is CE marked (including RoHS, EMC, etc).
Which other certificates we need to collect if we want to sell the tablet as part of our medical device in USA?
Thanks

Hi Julie
​
That's a great question to ask when you're defining the requirements!  Depending on what you're planning to do with this hypothetical thing, the functional, performance, and safety requirements could vary considerably.

For an android phone, the CE mark is still irrelevant and there may still be a lithium battery needing paperwork. The FCC rules are probably just a checkoff in the device specification... I don't know of any particular certificate you'd need to collect for that.

And yes, it's very important to figure out if the phone/tablet/thing is itself a medical device (or accessory) and if so then what classification. If you're being really creative with it, you might need to "collect" a PMA.​

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 23-Sep-2020 23:48
From: Julie Omohundro
Subject: tablet to be distributed in USA as part of a medical device

In what sense is it part of your medical device?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 11-Sep-2020 12:14
From: Anonymous Member
Subject: tablet to be distributed in USA as part of a medical device

This message was posted by a user wishing to remain anonymous

Hi all,
as part of our device we have a tablet provided by a European supplier. As such the tablet is CE marked (including RoHS, EMC, etc).
Which other certificates we need to collect if we want to sell the tablet as part of our medical device in USA?
Thanks

This message was posted by a user wishing to remain anonymous

Thank you all. 
Anne, going back to your point on the classification of the tablet (accessory vs. SaMD, etc).

In our case, we are definitely not a SaMD: our tablet is used to provide input data to the parent medical device. 
I struggle though understanding if it should be considered as an accessory or a component of the device. 

I listened to an FDA webinar some time ago (webinar on Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types - February 2, 2017) and there was a question on a "off-the-shelf mobile platform and the manufacturer designs software that runs on it. And this is part of a larger instrument that is considered a parent device."
At that time Bakul Patel from FDA answered: "it would not be considered as an accessory, but it would be the product, the component of the product itself."
 
You can check the transcripts of that webinar. 
Any thoughts on that? And whether there are practical differences in considering the tablet as an accessory or a component of the device?
Thanks for your feedback
Original Message:
Sent: 24-Sep-2020 12:03
From: Anne LeBlanc
Subject: tablet to be distributed in USA as part of a medical device

Hi Julie
​
That's a great question to ask when you're defining the requirements!  Depending on what you're planning to do with this hypothetical thing, the functional, performance, and safety requirements could vary considerably.

For an android phone, the CE mark is still irrelevant and there may still be a lithium battery needing paperwork. The FCC rules are probably just a checkoff in the device specification... I don't know of any particular certificate you'd need to collect for that.

And yes, it's very important to figure out if the phone/tablet/thing is itself a medical device (or accessory) and if so then what classification. If you're being really creative with it, you might need to "collect" a PMA.​

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 23-Sep-2020 23:48
From: Julie Omohundro
Subject: tablet to be distributed in USA as part of a medical device

In what sense is it part of your medical device?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 11-Sep-2020 12:14
From: Anonymous Member
Subject: tablet to be distributed in USA as part of a medical device

This message was posted by a user wishing to remain anonymous

Hi all,
as part of our device we have a tablet provided by a European supplier. As such the tablet is CE marked (including RoHS, EMC, etc).
Which other certificates we need to collect if we want to sell the tablet as part of our medical device in USA?
Thanks

This message was posted by a user wishing to remain anonymous

I do not believe a tablet would be an accessory because it fails the first test: it must be a medical device. And I don't believe a tablet would meet the definition of a medical device.

I think you should check out the Multiple Function Guidance. I think it would fall under that.
Original Message:
Sent: 11-Sep-2020 12:14
From: Anonymous Member
Subject: tablet to be distributed in USA as part of a medical device

This message was posted by a user wishing to remain anonymous

Hi all,
as part of our device we have a tablet provided by a European supplier. As such the tablet is CE marked (including RoHS, EMC, etc).
Which other certificates we need to collect if we want to sell the tablet as part of our medical device in USA?
Thanks

A tablet per se is not a medical device.  But a tablet that is used for a "medical purpose" as defined in a particular jurisdiction may well be a medical device, unless it has been specifically excluded as such within that jurisdiction.  It is generally not the nature of the contraption that makes it a medical device, but its intended use.

Quick skim of the multi-function guidance gives me the impression that CDRH may be digging itself deeper and deeper into a snarly software mess, but perhaps all of this makes more sense than is obvious to me. Not a high bar.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 25-Sep-2020 17:26
From: Anonymous Member
Subject: tablet to be distributed in USA as part of a medical device

This message was posted by a user wishing to remain anonymous

I do not believe a tablet would be an accessory because it fails the first test: it must be a medical device. And I don't believe a tablet would meet the definition of a medical device.

I think you should check out the Multiple Function Guidance. I think it would fall under that.
Original Message:
Sent: 11-Sep-2020 12:14
From: Anonymous Member
Subject: tablet to be distributed in USA as part of a medical device

This message was posted by a user wishing to remain anonymous

Hi all,
as part of our device we have a tablet provided by a European supplier. As such the tablet is CE marked (including RoHS, EMC, etc).
Which other certificates we need to collect if we want to sell the tablet as part of our medical device in USA?
Thanks