Regulatory Open Forum

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April Komplin, MS, CQA, CQIA

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If your device has already been approved by the NB, your CER must address every claim in the DFU. This is called safety & performance evaluation which is increasingly being asked for in NB reviews in the past couple of years. This is usually done through:
- a systematic review of clinical literature on your exact device (not a similar device or a market equivalent, although exceptions arise which may be permitted especially when the device is a legacy device without much recent clinical data). Data on predicates may be admissible provided you prove there are no significant changes in design, materials & clinical use. However predicates not registered in the EU are unlikely to be considered good candidates for comparison. Note that the clinical literature i'm referring to here is literature from the scientific database.
- analysis of clinical study on subject device, that is any clinical trials performed on subject device.
- evaluation of data collected through post-market surveillance - complaints, reportable events, recalls, field actions and proactive surveillance i.e. post market clinical followup and market evaluations/field assessments.
 Your clinical investigation is expected to address every claim you make in the DFU and newer claims (from off label use and extrapolatory benefits) cannot be made although clinical literature may contain such data. It may even be beneficial to create a matrix of claims in DFU, design input requirements and evidence for each claim from risk management and clinical literature.

If this clinical investigation is to support a new registration,  you would still need to address all of the applicable elements above. To answer your last question specifically, assuming you are going to conduct a clinical study, it may be permissible to use a few sample tissues and utilize clinical literature for the rest, but its best determined through risk assessment.

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Vidya
USA
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Original Message:
Sent: 08-Feb-2020 19:35
From: April Komplin
Subject: Advertising & Claims Limitations

Hi,

I have a Class IIa medical device system.
We will be performing a Clinical Investigation and a robust literature evaluation.
How can I better understand what advertising and claims limitations there are? And what limitations there are on our intended use statements as compared to what we formally investigate in our clinical investigation?

For example, our product can store various biological tissues, but we certainly won't be using all types in our clinical investigation. Is a literature evaluation enough to make the bridge and allow us to make the claims?

Thanks!

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April Komplin, MS, CQA, CQIA

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Without additional information, things to consider include if the statements are being made pre or post clearance, are they promotional or medical, who is the intended audience, etc. Take a look at FDA's website - they have some good guidances that cover some of these areas for drugs and devices (e.g., Medical Product Communications that are Consistent with FDA Labeling, ​Drug and Device Manufacturer Communications with payors, Distributing scientific and medical publications on unapproved new uses.....) If pre-clearance, consider the Federal Food, Drug and Cosmetic Act that speaks to general guidelines like "false and misleading". Also consider the integrity of your clinical investigations/recruitment when providing any statements/claims about the device.

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Alicia Whittlesey
Counsel and Director of Compliance Services at Porzio Bromberg & Newman P.C.
Westborough MA
United States
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Original Message:
Sent: 08-Feb-2020 19:35
From: April Komplin
Subject: Advertising & Claims Limitations

Hi,

I have a Class IIa medical device system.
We will be performing a Clinical Investigation and a robust literature evaluation.
How can I better understand what advertising and claims limitations there are? And what limitations there are on our intended use statements as compared to what we formally investigate in our clinical investigation?

For example, our product can store various biological tissues, but we certainly won't be using all types in our clinical investigation. Is a literature evaluation enough to make the bridge and allow us to make the claims?

Thanks!

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April Komplin, MS, CQA, CQIA

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Thank you both for your responses - very helpful. 

To add more detail: This is for pre-clearance in the EU under 2017/745.
Our product is unclassified by the US FDA.

Kind regards,
April

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April Komplin, MS, CQA, CQIA

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Original Message:
Sent: 10-Feb-2020 08:51
From: Alicia Whittlesey
Subject: Advertising & Claims Limitations

Without additional information, things to consider include if the statements are being made pre or post clearance, are they promotional or medical, who is the intended audience, etc. Take a look at FDA's website - they have some good guidances that cover some of these areas for drugs and devices (e.g., Medical Product Communications that are Consistent with FDA Labeling, ​Drug and Device Manufacturer Communications with payors, Distributing scientific and medical publications on unapproved new uses.....) If pre-clearance, consider the Federal Food, Drug and Cosmetic Act that speaks to general guidelines like "false and misleading". Also consider the integrity of your clinical investigations/recruitment when providing any statements/claims about the device.

------------------------------
Alicia Whittlesey
Counsel and Director of Compliance Services at Porzio Bromberg & Newman P.C.
Westborough MA
United States

Original Message:
Sent: 08-Feb-2020 19:35
From: April Komplin
Subject: Advertising & Claims Limitations

Hi,

I have a Class IIa medical device system.
We will be performing a Clinical Investigation and a robust literature evaluation.
How can I better understand what advertising and claims limitations there are? And what limitations there are on our intended use statements as compared to what we formally investigate in our clinical investigation?

For example, our product can store various biological tissues, but we certainly won't be using all types in our clinical investigation. Is a literature evaluation enough to make the bridge and allow us to make the claims?

Thanks!

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April Komplin, MS, CQA, CQIA

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