Regulatory Open Forum

My company has had "stand alone" software medical devices for some time now.  Recently, I have seen the term Software as a Medical Device (SaMD) pop-up.  I'm not sure I understand the difference?  Has a new category emerged? Is there a difference between a medical device that happens to be software and SaMD?

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Rene' Hardee
Regulatory Affairs Specialist III
Sun Nuclear Corporation
Melbourne FL
United States
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They refer to the same thing.  "SaMD" is the term used by the IMDRF.

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

Original Message:
Sent: 27-Oct-2016 16:48
From: Rene' Hardee
Subject: SaMD terminology change?

My company has had "stand alone" software medical devices for some time now.  Recently, I have seen the term Software as a Medical Device (SaMD) pop-up.  I'm not sure I understand the difference?  Has a new category emerged? Is there a difference between a medical device that happens to be software and SaMD?

------------------------------
Rene' Hardee
Regulatory Affairs Specialist III
Sun Nuclear Corporation
Melbourne FL
United States
------------------------------

In case you haven't seen it:

https://www.gpo.gov/fdsys/pkg/FR-2016-10-14/html/2016-24805.htm

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

Original Message:
Sent: 27-Oct-2016 16:48
From: Rene' Hardee
Subject: SaMD terminology change?

My company has had "stand alone" software medical devices for some time now.  Recently, I have seen the term Software as a Medical Device (SaMD) pop-up.  I'm not sure I understand the difference?  Has a new category emerged? Is there a difference between a medical device that happens to be software and SaMD?

------------------------------
Rene' Hardee
Regulatory Affairs Specialist III
Sun Nuclear Corporation
Melbourne FL
United States
------------------------------

This one is really interesting because I think this is the first time the US FDA has proposed adopting the CER (clinical evaluation report) structure from the EU for a medical device (software in this case). Has anyone seen the FDA requiring a CER before? I've seen similar types of report requirements just not so verbatim from the EU Notified Body review system.

Sent from my iPhone


Original Message------

In case you haven't seen it:

https://www.gpo.gov/fdsys/pkg/FR-2016-10-14/html/2016-24805.htm

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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I agree.  Until now, I've thought of the Report of Prior Investigations as the closest thing the US regulatory scheme has to the EU CER.

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

Original Message:
Sent: 30-Oct-2016 11:22
From: Joy Frestedt
Subject: SaMD terminology change?

This one is really interesting because I think this is the first time the US FDA has proposed adopting the CER (clinical evaluation report) structure from the EU for a medical device (software in this case). Has anyone seen the FDA requiring a CER before? I've seen similar types of report requirements just not so verbatim from the EU Notified Body review system.

Sent from my iPhone

From a regulatory perspective, it is seems that this guidance evolved out of IMDRF, rather than FDA. I think that this language is likely to lead to some confusion for US device companies, especially those that deal mostly with FDA:

"For all medical devices, clinical evaluation, a process activity that is conducted during a product’s lifecycle as part of the quality management system"

I don't think most US device companies think a clinical evaluation is part of either the QSR or ISO 13485.  Am I wrong on this?

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

Original Message:
Sent: 30-Oct-2016 11:22
From: Joy Frestedt
Subject: SaMD terminology change?

This one is really interesting because I think this is the first time the US FDA has proposed adopting the CER (clinical evaluation report) structure from the EU for a medical device (software in this case). Has anyone seen the FDA requiring a CER before? I've seen similar types of report requirements just not so verbatim from the EU Notified Body review system.

Sent from my iPhone

I think at least one interpretation of ISO 13485:2016 is that it will require a clinical evaluation as part of the quality system.

g-

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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States

Original Message:
Sent: 31-Oct-2016 13:06
From: Julie Omohundro
Subject: SaMD terminology change?

From a regulatory perspective, it is seems that this guidance evolved out of IMDRF, rather than FDA. I think that this language is likely to lead to some confusion for US device companies, especially those that deal mostly with FDA:

"For all medical devices, clinical evaluation, a process activity that is conducted during a product’s lifecycle as part of the quality management system"

I don't think most US device companies think a clinical evaluation is part of either the QSR or ISO 13485.  Am I wrong on this?

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

Original Message:
Sent: 30-Oct-2016 11:22
From: Joy Frestedt
Subject: SaMD terminology change?

This one is really interesting because I think this is the first time the US FDA has proposed adopting the CER (clinical evaluation report) structure from the EU for a medical device (software in this case). Has anyone seen the FDA requiring a CER before? I've seen similar types of report requirements just not so verbatim from the EU Notified Body review system.

Sent from my iPhone

Original Message------

I think at least one interpretation of ISO 13485:2016 is that it will require a clinical evaluation as part of the quality system.

g-

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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Actually, that's the reason I find it surprising. 

This is the first time FDA has shown any interest in clinical evaluations, to the extent that I would say there is no official evidence it was even aware of them, perhaps until it encountered them via the IMDRF.  In the meantime, they've been part of the regulatory scheme in the EU and some other jurisdictions for years now.

What is notable about the MDD requirement is that it is applicable to Class I devices, where previously I'm not sure FDA had ever used "Class I and "clinical" in the same breath.  Moreover, the mobile apps crowd has been insisting hopefully that "most software devices are low risk."  I didn’t see anything in the guidance to indicate that this requirement is not applicable to Class I devices. In that case, it appears that FDA has agreed to raise its bar for these low-risk devices to the same height as some of the other key players have already set it within their own jurisdictions, but I do not see how FDA is the probable prime mover on this one.

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

Original Message:
Sent: 01-Nov-2016 07:46
From: Ginger Cantor
Subject: SaMD terminology change?

Since FDA IS a key player in IMDRF, this should not be surprising. Just the next flavor of GHTF. 

Ginger Cantor, MBA, RAC
Centaur Consulting LLC