Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Happy New Year everyone.

I am looking for others point of view.

Per definition, the term "Software as a Medical Device" (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
NOTES:
• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.
• SaMD is capable of running on general purpose (non-medical purpose) computing platforms
• "without being part of" means software not necessary for a hardware medical device to achieve its intended medical purpose;
• Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
• SaMD may be used in combination (e.g., as a module) with other products including medical devices;
• SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software
• Mobile apps that meet the definition above are considered SaMD

I was wondering if a software developed to be used with commercially available instruments to manufacture a specific drug/biologic can be considered a SaMD? The intent would be to add a specific intended use when the software is used with the instrument. 
There is some difference in opinion about bullet 4, and I was wondering if bullet 4 will discount the option of developing a SaMD with a manufacturing purpose.

Hello Anon,

The simple answer is no.  Software which is used in production, manufacturing, quality system, or other non-final use instances are often referred to as Non-Product Software (NPS) and would not be considered a Software as Medical Device (SaMD).  However, the software would need to be considered in the manufacturing process for qualification or validation for how it contributes to the final drug/biologic/medical device product.  Though your question is not quite so clear because you make a further statement 'the intent would be to add a specific intended use when the software is used' so some software could still be considered a SaMD if used as an accessory to another medical product.

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

Original Message:
Sent: 03-Jan-2023 12:26
From: Anonymous Member
Subject: SaMD with a manufacturing purpose

This message was posted by a user wishing to remain anonymous

Happy New Year everyone.

I am looking for others point of view.

Per definition, the term "Software as a Medical Device" (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
NOTES:
• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.
• SaMD is capable of running on general purpose (non-medical purpose) computing platforms
• "without being part of" means software not necessary for a hardware medical device to achieve its intended medical purpose;
• Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
• SaMD may be used in combination (e.g., as a module) with other products including medical devices;
• SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software
• Mobile apps that meet the definition above are considered SaMD

I was wondering if a software developed to be used with commercially available instruments to manufacture a specific drug/biologic can be considered a SaMD? The intent would be to add a specific intended use when the software is used with the instrument.
There is some difference in opinion about bullet 4, and I was wondering if bullet 4 will discount the option of developing a SaMD with a manufacturing purpose.

Hello Richard,

Based on what you said if, for example, you have robotic surgery equipment which uses software than that would also be considered 'software as medical device'. Would that be correct?

Thank you for always being so helpful,
Olga

------------------------------
Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
olga.peycheva@solutionsop.co.uk
United Kingdom
------------------------------

Original Message:
Sent: 04-Jan-2023 01:36
From: Richard Vincins
Subject: SaMD with a manufacturing purpose

Hello Anon,

The simple answer is no.  Software which is used in production, manufacturing, quality system, or other non-final use instances are often referred to as Non-Product Software (NPS) and would not be considered a Software as Medical Device (SaMD).  However, the software would need to be considered in the manufacturing process for qualification or validation for how it contributes to the final drug/biologic/medical device product.  Though your question is not quite so clear because you make a further statement 'the intent would be to add a specific intended use when the software is used' so some software could still be considered a SaMD if used as an accessory to another medical product.

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

Original Message:
Sent: 03-Jan-2023 12:26
From: Anonymous Member
Subject: SaMD with a manufacturing purpose

This message was posted by a user wishing to remain anonymous

Happy New Year everyone.

I am looking for others point of view.

Per definition, the term "Software as a Medical Device" (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
NOTES:
• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.
• SaMD is capable of running on general purpose (non-medical purpose) computing platforms
• "without being part of" means software not necessary for a hardware medical device to achieve its intended medical purpose;
• Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
• SaMD may be used in combination (e.g., as a module) with other products including medical devices;
• SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software
• Mobile apps that meet the definition above are considered SaMD

I was wondering if a software developed to be used with commercially available instruments to manufacture a specific drug/biologic can be considered a SaMD? The intent would be to add a specific intended use when the software is used with the instrument.
There is some difference in opinion about bullet 4, and I was wondering if bullet 4 will discount the option of developing a SaMD with a manufacturing purpose.

Olga,
If the software is required by the robotic surgery hardware device to perform its intended use, it belongs to Software in a Medical Device (not SaMD) while the robotic surgery equipment is considered as the medical device. Very often, they are referred to as Embedded Software.

However, if the software is connected to robotic surgery equipment but is not needed by robotic surgery equipment to achieve its intended medical purpose, then it is Software as a Medical Device (SaMD).

------------------------------
Haiyan Wei
Sr. Regulatory Affairs Specialist
Irvine CA
United States
------------------------------

Original Message:
Sent: 04-Jan-2023 04:36
From: Olga Peycheva
Subject: SaMD with a manufacturing purpose

Hello Richard,

Based on what you said if, for example, you have robotic surgery equipment which uses software than that would also be considered 'software as medical device'. Would that be correct?

Thank you for always being so helpful,
Olga

------------------------------
Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
olga.peycheva@solutionsop.co.uk
United Kingdom

Original Message:
Sent: 04-Jan-2023 01:36
From: Richard Vincins
Subject: SaMD with a manufacturing purpose

Hello Anon,

The simple answer is no.  Software which is used in production, manufacturing, quality system, or other non-final use instances are often referred to as Non-Product Software (NPS) and would not be considered a Software as Medical Device (SaMD).  However, the software would need to be considered in the manufacturing process for qualification or validation for how it contributes to the final drug/biologic/medical device product.  Though your question is not quite so clear because you make a further statement 'the intent would be to add a specific intended use when the software is used' so some software could still be considered a SaMD if used as an accessory to another medical product.

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

Original Message:
Sent: 03-Jan-2023 12:26
From: Anonymous Member
Subject: SaMD with a manufacturing purpose

This message was posted by a user wishing to remain anonymous

Happy New Year everyone.

I am looking for others point of view.

Per definition, the term "Software as a Medical Device" (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
NOTES:
• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.
• SaMD is capable of running on general purpose (non-medical purpose) computing platforms
• "without being part of" means software not necessary for a hardware medical device to achieve its intended medical purpose;
• Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
• SaMD may be used in combination (e.g., as a module) with other products including medical devices;
• SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software
• Mobile apps that meet the definition above are considered SaMD

I was wondering if a software developed to be used with commercially available instruments to manufacture a specific drug/biologic can be considered a SaMD? The intent would be to add a specific intended use when the software is used with the instrument.
There is some difference in opinion about bullet 4, and I was wondering if bullet 4 will discount the option of developing a SaMD with a manufacturing purpose.

I concur with Richard's response - software utilized during drug/biologic/device manufacturing is subject to the applicable cGMPs as a part of said manufacturing and is not a product in its own right, and, thus not SaMD. There is separate guidance to handle such manufacturing software, e.g. FDA's recent draft guidance (promulgated by CDRH and CBER for medical devices) titled Computer Software Assurance for Production and Quality System Software.

The clause that is quoted concerning driving a hardware medical device may also be called 'Software in a Medical Device' (SiMD), firmware, or embedded software - think about the software used to operate electromechanical medical devices (such as infusion pumps). Such software is handled as a part of the entire medical device system and not independently (as in the case of SaMD), hence why the clause exists.

------------------------------
Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States
------------------------------

Original Message:
Sent: 04-Jan-2023 01:36
From: Richard Vincins
Subject: SaMD with a manufacturing purpose

Hello Anon,

The simple answer is no.  Software which is used in production, manufacturing, quality system, or other non-final use instances are often referred to as Non-Product Software (NPS) and would not be considered a Software as Medical Device (SaMD).  However, the software would need to be considered in the manufacturing process for qualification or validation for how it contributes to the final drug/biologic/medical device product.  Though your question is not quite so clear because you make a further statement 'the intent would be to add a specific intended use when the software is used' so some software could still be considered a SaMD if used as an accessory to another medical product.

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

Original Message:
Sent: 03-Jan-2023 12:26
From: Anonymous Member
Subject: SaMD with a manufacturing purpose

This message was posted by a user wishing to remain anonymous

Happy New Year everyone.

I am looking for others point of view.

Per definition, the term "Software as a Medical Device" (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
NOTES:
• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.
• SaMD is capable of running on general purpose (non-medical purpose) computing platforms
• "without being part of" means software not necessary for a hardware medical device to achieve its intended medical purpose;
• Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
• SaMD may be used in combination (e.g., as a module) with other products including medical devices;
• SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software
• Mobile apps that meet the definition above are considered SaMD

I was wondering if a software developed to be used with commercially available instruments to manufacture a specific drug/biologic can be considered a SaMD? The intent would be to add a specific intended use when the software is used with the instrument.
There is some difference in opinion about bullet 4, and I was wondering if bullet 4 will discount the option of developing a SaMD with a manufacturing purpose.

This message was posted by a user wishing to remain anonymous

Hi Richard,

Thank you for your response. The reason why I said "the intent would be to add a specific intended use when the software is used, is because the scenario I described would be to just sell the software. The proprietary software will provide the ability to produce a drug/biologic. But you have provided clarity already as the caveat with the scenario I described is that the software could be used with a lab instrument instead of another medical device. From my experience that may be ok for research purposes, but not ok if the biologic is needed for human use, but I wanted to hear others perspective and both you and Jonathan confirmed my thoughts.
Original Message:
Sent: 04-Jan-2023 01:36
From: Richard Vincins
Subject: SaMD with a manufacturing purpose

Hello Anon,

The simple answer is no.  Software which is used in production, manufacturing, quality system, or other non-final use instances are often referred to as Non-Product Software (NPS) and would not be considered a Software as Medical Device (SaMD).  However, the software would need to be considered in the manufacturing process for qualification or validation for how it contributes to the final drug/biologic/medical device product.  Though your question is not quite so clear because you make a further statement 'the intent would be to add a specific intended use when the software is used' so some software could still be considered a SaMD if used as an accessory to another medical product.

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

Original Message:
Sent: 03-Jan-2023 12:26
From: Anonymous Member
Subject: SaMD with a manufacturing purpose

This message was posted by a user wishing to remain anonymous

Happy New Year everyone.

I am looking for others point of view.

Per definition, the term "Software as a Medical Device" (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
NOTES:
• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.
• SaMD is capable of running on general purpose (non-medical purpose) computing platforms
• "without being part of" means software not necessary for a hardware medical device to achieve its intended medical purpose;
• Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
• SaMD may be used in combination (e.g., as a module) with other products including medical devices;
• SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software
• Mobile apps that meet the definition above are considered SaMD

I was wondering if a software developed to be used with commercially available instruments to manufacture a specific drug/biologic can be considered a SaMD? The intent would be to add a specific intended use when the software is used with the instrument.
There is some difference in opinion about bullet 4, and I was wondering if bullet 4 will discount the option of developing a SaMD with a manufacturing purpose.