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This message was posted by a user wishing to remain anonymous

Is ISO 20916, Clinical Performance Studies Using Specimens from Human Subjects, applicable only within the EU? The standard was included in the IVDR Corrigendum (replaced reference to ISO 14155), however I am having a hard time understanding if this standard can or should also be applied to US clinical studies. FDA does not yet recognize the standard, although they do recognize 14155. Maybe another way to ask the question - is a "clinical performance study" specifically an EU term?

Thank you for any help you can provide.

My understanding is that if you are testing performance of a medical device, ISO 14155 is the appropriate standard, and if you are testing an IVD, ISO 20916 is the appropriate standard.

FDA recognizes ISO 14155 but not ISO 20916. This doesn't mean you can't use ISO 20916 for an FDA submission, it just means that the reviewers will not have access to that standard or be familiar with it. So you have little to gain by using it. Also the fact that FDA recognizes ISO 14155 does not necessarily mean that it is required. In fact, ISO 14155 is far stricter than FDA GCP requirements.

The primary difference between the two standards is that ISO 14155 is intended for "Medical Devices" which interact with human subjects, while ISO 20916 is for "Medical Devices" which only use specimens derived from human subjects. The term "clinical investigation" in EU parlance refers to s study done on human subjects, which invokes ISO 14155, while a "clinical performance evaluation" makes clear that the study was not done on humans, but on specimens derived from humans, which invoke ISO 29016.

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Jean Bigoney PhD, RAC, CQE
Senior Regulatory Affairs Specialist
Morrisville NC
United States
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Original Message:
Sent: 22-Jun-2021 17:34
From: Anonymous Member
Subject: ISO 20916 applicability

This message was posted by a user wishing to remain anonymous

Is ISO 20916, Clinical Performance Studies Using Specimens from Human Subjects, applicable only within the EU? The standard was included in the IVDR Corrigendum (replaced reference to ISO 14155), however I am having a hard time understanding if this standard can or should also be applied to US clinical studies. FDA does not yet recognize the standard, although they do recognize 14155. Maybe another way to ask the question - is a "clinical performance study" specifically an EU term?

Thank you for any help you can provide.

Hello,

Completely support explanation by Jean, spot on.  Just keep in mind you should still be following ISO 14155 because this has many of the Good Clinical Practice (GCP) items in there such as protocols, informed consent, ethics approval, etc., all which are still required for any type of clinical performance study of IVDs.  While ISO 20916 does have much of this information, I think there is still some basic information contained in ISO 14155.  In addition, if you are using medical devices for sample collection then ISO 14155 should also be used (which is a note in the ISO 20916 standard).

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Jun-2021 14:57
From: Jean Bigoney
Subject: ISO 20916 applicability

My understanding is that if you are testing performance of a medical device, ISO 14155 is the appropriate standard, and if you are testing an IVD, ISO 20916 is the appropriate standard.

FDA recognizes ISO 14155 but not ISO 20916. This doesn't mean you can't use ISO 20916 for an FDA submission, it just means that the reviewers will not have access to that standard or be familiar with it. So you have little to gain by using it. Also the fact that FDA recognizes ISO 14155 does not necessarily mean that it is required. In fact, ISO 14155 is far stricter than FDA GCP requirements.

The primary difference between the two standards is that ISO 14155 is intended for "Medical Devices" which interact with human subjects, while ISO 20916 is for "Medical Devices" which only use specimens derived from human subjects. The term "clinical investigation" in EU parlance refers to s study done on human subjects, which invokes ISO 14155, while a "clinical performance evaluation" makes clear that the study was not done on humans, but on specimens derived from humans, which invoke ISO 29016.

------------------------------
Jean Bigoney PhD, RAC, CQE
Senior Regulatory Affairs Specialist
Morrisville NC
United States

Original Message:
Sent: 22-Jun-2021 17:34
From: Anonymous Member
Subject: ISO 20916 applicability

This message was posted by a user wishing to remain anonymous

Is ISO 20916, Clinical Performance Studies Using Specimens from Human Subjects, applicable only within the EU? The standard was included in the IVDR Corrigendum (replaced reference to ISO 14155), however I am having a hard time understanding if this standard can or should also be applied to US clinical studies. FDA does not yet recognize the standard, although they do recognize 14155. Maybe another way to ask the question - is a "clinical performance study" specifically an EU term?

Thank you for any help you can provide.

This message was posted by a user wishing to remain anonymous

Thank you Jean! Greatly appreciate your thoughts on this matter, and what you said makes sense.
Original Message:
Sent: 23-Jun-2021 14:57
From: Jean Bigoney
Subject: ISO 20916 applicability

My understanding is that if you are testing performance of a medical device, ISO 14155 is the appropriate standard, and if you are testing an IVD, ISO 20916 is the appropriate standard.

FDA recognizes ISO 14155 but not ISO 20916. This doesn't mean you can't use ISO 20916 for an FDA submission, it just means that the reviewers will not have access to that standard or be familiar with it. So you have little to gain by using it. Also the fact that FDA recognizes ISO 14155 does not necessarily mean that it is required. In fact, ISO 14155 is far stricter than FDA GCP requirements.

The primary difference between the two standards is that ISO 14155 is intended for "Medical Devices" which interact with human subjects, while ISO 20916 is for "Medical Devices" which only use specimens derived from human subjects. The term "clinical investigation" in EU parlance refers to s study done on human subjects, which invokes ISO 14155, while a "clinical performance evaluation" makes clear that the study was not done on humans, but on specimens derived from humans, which invoke ISO 29016.

------------------------------
Jean Bigoney PhD, RAC, CQE
Senior Regulatory Affairs Specialist
Morrisville NC
United States

Original Message:
Sent: 22-Jun-2021 17:34
From: Anonymous Member
Subject: ISO 20916 applicability

This message was posted by a user wishing to remain anonymous

Is ISO 20916, Clinical Performance Studies Using Specimens from Human Subjects, applicable only within the EU? The standard was included in the IVDR Corrigendum (replaced reference to ISO 14155), however I am having a hard time understanding if this standard can or should also be applied to US clinical studies. FDA does not yet recognize the standard, although they do recognize 14155. Maybe another way to ask the question - is a "clinical performance study" specifically an EU term?

Thank you for any help you can provide.

Just out of curiosity, I did a quick search on our system and found that 59 510(k)s and one de novo mention ISO 14155, while zero applications of any type mention ISO 20916 (at least in their public documents).

------------------------------
Ross Meisner
Chief Commercial Officer
Boston MA
------------------------------

Original Message:
Sent: 23-Jun-2021 20:40
From: Anonymous Member
Subject: ISO 20916 applicability

This message was posted by a user wishing to remain anonymous

Thank you Jean! Greatly appreciate your thoughts on this matter, and what you said makes sense.
Original Message:
Sent: 23-Jun-2021 14:57
From: Jean Bigoney
Subject: ISO 20916 applicability

My understanding is that if you are testing performance of a medical device, ISO 14155 is the appropriate standard, and if you are testing an IVD, ISO 20916 is the appropriate standard.

FDA recognizes ISO 14155 but not ISO 20916. This doesn't mean you can't use ISO 20916 for an FDA submission, it just means that the reviewers will not have access to that standard or be familiar with it. So you have little to gain by using it. Also the fact that FDA recognizes ISO 14155 does not necessarily mean that it is required. In fact, ISO 14155 is far stricter than FDA GCP requirements.

The primary difference between the two standards is that ISO 14155 is intended for "Medical Devices" which interact with human subjects, while ISO 20916 is for "Medical Devices" which only use specimens derived from human subjects. The term "clinical investigation" in EU parlance refers to s study done on human subjects, which invokes ISO 14155, while a "clinical performance evaluation" makes clear that the study was not done on humans, but on specimens derived from humans, which invoke ISO 29016.

------------------------------
Jean Bigoney PhD, RAC, CQE
Senior Regulatory Affairs Specialist
Morrisville NC
United States

Original Message:
Sent: 22-Jun-2021 17:34
From: Anonymous Member
Subject: ISO 20916 applicability

This message was posted by a user wishing to remain anonymous

Is ISO 20916, Clinical Performance Studies Using Specimens from Human Subjects, applicable only within the EU? The standard was included in the IVDR Corrigendum (replaced reference to ISO 14155), however I am having a hard time understanding if this standard can or should also be applied to US clinical studies. FDA does not yet recognize the standard, although they do recognize 14155. Maybe another way to ask the question - is a "clinical performance study" specifically an EU term?

Thank you for any help you can provide.