Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello RAPS! What is the current guideline in mentioning U.S. FDA or "U.S. FDA-approved" statement on promotional documents? Our sales team is creating a certificate of authenticity for medical equipment sold in our country to guarantee patients that the product they are using is safe and cleared by regulatory bodies. I am from APAC region and this kind of statement is discouraged by local authorities.

Thank you in advance!

Hello Anon,

It is also discouraged by U.S. FDA as they do not want to appear any type of endorsement or as you said "certificate of authenticity" for devices cleared or approved in the U.S.  However, you can state the facts such as "Cleared in U.S. under K214598" or "Approved in U.S. by PMA P216789".  Just be cautious on these statements because "promoting" this fact making it seem like an endorsement needs to be carefully conveyed.  As an example, you could put somewhere low in smaller print on a brochure K214598 Cleared or something.  Instead of perceived promotion have a big shiny star on the top of the brochure saying Successfully Approved in US by K214598.  Myself, I always tried to discourage sales and marketing from including this information because you are right many local authorities discourage these approaches.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 05-Nov-2021 02:53
From: Anonymous Member
Subject: Use of "U.S. FDA-approved" statement

This message was posted by a user wishing to remain anonymous

Hello RAPS! What is the current guideline in mentioning U.S. FDA or "U.S. FDA-approved" statement on promotional documents? Our sales team is creating a certificate of authenticity for medical equipment sold in our country to guarantee patients that the product they are using is safe and cleared by regulatory bodies. I am from APAC region and this kind of statement is discouraged by local authorities.

Thank you in advance!

Original Message:
Sent: 11/5/2021 2:53:00 AM
From: Anonymous Member
Subject: Use of "U.S. FDA-approved" statement

This message was posted by a user wishing to remain anonymous

Hello RAPS! What is the current guideline in mentioning U.S. FDA or "U.S. FDA-approved" statement on promotional documents? Our sales team is creating a certificate of authenticity for medical equipment sold in our country to guarantee patients that the product they are using is safe and cleared by regulatory bodies. I am from APAC region and this kind of statement is discouraged by local authorities.

Thank you in advance!

First, FDA's official regulatory requirement is that for a 510(k)-cleared device, any representation creating an impression of official FDA approval of the device is misleading and constitutes misbranding (i.e., a violation of FDA law).  That said, FDA does with certain limitations permit us to state that a 510(k)-cleared device has received 510(k)-clearance and to reference the 510(k) number.  Specifically, FDA's position is that the such statements are not to be used in a promotional context (e.g., in advertising materials, websites, etc.), but simply as a statement of fact when warranted in a non-promotional context.

The story is different for PMA-approved devices.  Specifically, FDA's traditional policy has been that we can say "FDA approved" and the like for PMA-approved devices.  That policy hasn't changed as far as I know.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 05-Nov-2021 02:53
From: Anonymous Member
Subject: Use of "U.S. FDA-approved" statement

This message was posted by a user wishing to remain anonymous

Hello RAPS! What is the current guideline in mentioning U.S. FDA or "U.S. FDA-approved" statement on promotional documents? Our sales team is creating a certificate of authenticity for medical equipment sold in our country to guarantee patients that the product they are using is safe and cleared by regulatory bodies. I am from APAC region and this kind of statement is discouraged by local authorities.

Thank you in advance!

Kevin' response is most accurate here.

You cannot refer to FDA 510k clearance or device listing or company registration in any promotional way or use their logo.  It is considered misbranding under 21 CFR 807.  

This is because most people do not understand the difference between a "clearance " and a full PMA type approval.  If you mention FDA clearance WITHOUT explaining the difference between clearance versus approval clearly (with additional text), it is misbranding. 

I NEVER advise companies they can use the 510(k) number on sales items, product brochures, websites , flyers, etc.  They can use it in an initial press release when they get it, but it is generally a one time deal.  It can be used if a distributor asks you for it to confirm it is cleared, or during import into US, or perhaps another branch of the US government (VA medical centers) for a purchase contract or an IRB wants to have it for confirmation if there are ongoing studies. If someone asks, yes you can confirm, but again, not promtionally.

But you can use Approved for an approved PMA (Class 3 devices) in promotional settings /materials.  

FDA has recently sent out warning letters for this, and they typically find out you are doing it by paying attenttion to ads, attending conferences and reviewing websites.  Even more frequently,  your competitors turn you in to FDA for misbranding.  I have turned in companies for this.  It is a misleading unfair marketing practice to advertise a 510k clearance.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 06-Nov-2021 13:54
From: Kevin Randall, RAC
Subject: Use of "U.S. FDA-approved" statement

First, FDA's official regulatory requirement is that for a 510(k)-cleared device, any representation creating an impression of official FDA approval of the device is misleading and constitutes misbranding (i.e., a violation of FDA law).  That said, FDA does with certain limitations permit us to state that a 510(k)-cleared device has received 510(k)-clearance and to reference the 510(k) number.  Specifically, FDA's position is that the such statements are not to be used in a promotional context (e.g., in advertising materials, websites, etc.), but simply as a statement of fact when warranted in a non-promotional context.

The story is different for PMA-approved devices.  Specifically, FDA's traditional policy has been that we can say "FDA approved" and the like for PMA-approved devices.  That policy hasn't changed as far as I know.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 05-Nov-2021 02:53
From: Anonymous Member
Subject: Use of "U.S. FDA-approved" statement

This message was posted by a user wishing to remain anonymous

Hello RAPS! What is the current guideline in mentioning U.S. FDA or "U.S. FDA-approved" statement on promotional documents? Our sales team is creating a certificate of authenticity for medical equipment sold in our country to guarantee patients that the product they are using is safe and cleared by regulatory bodies. I am from APAC region and this kind of statement is discouraged by local authorities.

Thank you in advance!

The public has a vague appreciation for the work the FDA does and so using the term FDA Approves conveys something greater than what it is.

It would be like "Joe Smith, approved by the State of Ohio for driving a car at highway speeds" to overreach on what a driver's license means or putting "Not a felon" on your resume. Its the lowest bar and should be assumed.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 07-Nov-2021 06:21
From: Ginger Cantor
Subject: Use of "U.S. FDA-approved" statement

Kevin' response is most accurate here.

You cannot refer to FDA 510k clearance or device listing or company registration in any promotional way or use their logo.  It is considered misbranding under 21 CFR 807.

This is because most people do not understand the difference between a "clearance " and a full PMA type approval.  If you mention FDA clearance WITHOUT explaining the difference between clearance versus approval clearly (with additional text), it is misbranding.

I NEVER advise companies they can use the 510(k) number on sales items, product brochures, websites , flyers, etc.  They can use it in an initial press release when they get it, but it is generally a one time deal.  It can be used if a distributor asks you for it to confirm it is cleared, or during import into US, or perhaps another branch of the US government (VA medical centers) for a purchase contract or an IRB wants to have it for confirmation if there are ongoing studies. If someone asks, yes you can confirm, but again, not promtionally.

But you can use Approved for an approved PMA (Class 3 devices) in promotional settings /materials.

FDA has recently sent out warning letters for this, and they typically find out you are doing it by paying attenttion to ads, attending conferences and reviewing websites.  Even more frequently,  your competitors turn you in to FDA for misbranding.  I have turned in companies for this.  It is a misleading unfair marketing practice to advertise a 510k clearance.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 06-Nov-2021 13:54
From: Kevin Randall, RAC
Subject: Use of "U.S. FDA-approved" statement

First, FDA's official regulatory requirement is that for a 510(k)-cleared device, any representation creating an impression of official FDA approval of the device is misleading and constitutes misbranding (i.e., a violation of FDA law).  That said, FDA does with certain limitations permit us to state that a 510(k)-cleared device has received 510(k)-clearance and to reference the 510(k) number.  Specifically, FDA's position is that the such statements are not to be used in a promotional context (e.g., in advertising materials, websites, etc.), but simply as a statement of fact when warranted in a non-promotional context.

The story is different for PMA-approved devices.  Specifically, FDA's traditional policy has been that we can say "FDA approved" and the like for PMA-approved devices.  That policy hasn't changed as far as I know.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 05-Nov-2021 02:53
From: Anonymous Member
Subject: Use of "U.S. FDA-approved" statement

This message was posted by a user wishing to remain anonymous

Hello RAPS! What is the current guideline in mentioning U.S. FDA or "U.S. FDA-approved" statement on promotional documents? Our sales team is creating a certificate of authenticity for medical equipment sold in our country to guarantee patients that the product they are using is safe and cleared by regulatory bodies. I am from APAC region and this kind of statement is discouraged by local authorities.

Thank you in advance!