Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I'm relatively new to research and I'm trying to further understand IDE exemptions. Specifically, I am interested in how "basic physiological" research works. What should or should not be in a protocol with unapproved devices in order for it to not require an IDE under this category?

Thank you for any help you can provide.

HI I have been in the med dev industry for over 30 yrs and in clinical research.....your question is jumbled....ID "Exemption" is that your company and research is not under those FDA regulations  for a commercial device, i. e., MDR reporting, labeling, QSR, etc.  The IDE data is all confidential and will not be disclosed to the public until you receive your 510K. De Novo designation, or PMA...... so if you had a Unanticipated Adverse Event in the study it gets reported to FDA and not via the MDR reporting....not sure what you referred to in the other part of your question.....thx Susanne

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Susanne Smith MSN
Biomedical Regulatory Device Consultant
STS Biomedical Consulting
Englewood FL
United States
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Original Message:
Sent: 22-Sep-2017 13:35
From: Anonymous Member
Subject: IDE exemptions

This message was posted by a user wishing to remain anonymous

Hello,

I'm relatively new to research and I'm trying to further understand IDE exemptions. Specifically, I am interested in how "basic physiological" research works. What should or should not be in a protocol with unapproved devices in order for it to not require an IDE under this category?

Thank you for any help you can provide.

I believe the OP was asking about types of studies that are exempt from requiring an IDE.  The question referenced physiological research, and so if I have interpreted this correctly, then this would be exempt.  A device that was developed to help answer a physiological question and for which there is no intention to develop it for medical use is not covered by FDA regulation.  This is not to say that issues of safety and human protections would not need to be considered, but these are issues that would be addressed by which ever IRB was required to oversee the study.

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Joshua Lowndes
Orlando FL
United States
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Original Message:
Sent: 26-Sep-2017 14:02
From: Susanne Smith
Subject: IDE exemptions

HI I have been in the med dev industry for over 30 yrs and in clinical research.....your question is jumbled....ID "Exemption" is that your company and research is not under those FDA regulations  for a commercial device, i. e., MDR reporting, labeling, QSR, etc.  The IDE data is all confidential and will not be disclosed to the public until you receive your 510K. De Novo designation, or PMA...... so if you had a Unanticipated Adverse Event in the study it gets reported to FDA and not via the MDR reporting....not sure what you referred to in the other part of your question.....thx Susanne

------------------------------
Susanne Smith MSN
Biomedical Regulatory Device Consultant
STS Biomedical Consulting
Englewood FL
United States

Original Message:
Sent: 22-Sep-2017 13:35
From: Anonymous Member
Subject: IDE exemptions

This message was posted by a user wishing to remain anonymous

Hello,

I'm relatively new to research and I'm trying to further understand IDE exemptions. Specifically, I am interested in how "basic physiological" research works. What should or should not be in a protocol with unapproved devices in order for it to not require an IDE under this category?

Thank you for any help you can provide.