Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

If you are introducing a new product under an already approved 510K, via letter to file, can marketing material state "FDA cleared"?  If so, what is the notification process to the FDA of the new product? Update Medical Device Listing?

It would not be ok to put on marketing material FDA Cleared - make sure there are no inference or other statements implying endorsement of the product by FDA.

There is not a notification process to FDA - you would just update your Medical Device Listing with the new product.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 21-Aug-2019 17:06
From: Anonymous Member
Subject: Letter to File

This message was posted by a user wishing to remain anonymous

If you are introducing a new product under an already approved 510K, via letter to file, can marketing material state "FDA cleared"?  If so, what is the notification process to the FDA of the new product? Update Medical Device Listing?

Actually Richard,

It is NOT allowable to use FDA cleared without also clearly explaining the difference between a Clearance and an Approval .  FDA regulation states this is misbranding without sufficient explanation because of the level of rigor applied in review for a 510(k) versus a PMA. And just putting your 510(k) number alone on marketing pieces or website is misbranding.

This is similar to using the FDA logo, a definite no-no that will draw a warning letter if discovered.

Don't have the CFR reference at close hand, but look partly at Section 502 of the FD&C Act.   With the 1997 Amendments, PMAs were allowed to use their # , but not 510(k) unless you really explain clearance versus approval.

 ​

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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
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Original Message:
Sent: 23-Aug-2019 05:43
From: Richard Vincins
Subject: Letter to File

Yes, it is acceptable to put on marketing material FDA Cleared - but make sure there are no inference or other statements implying endorsement of the product by FDA.

There is not a notification process to FDA - you would just update your Medical Device Listing with the new product.

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

Original Message:
Sent: 21-Aug-2019 17:06
From: Anonymous Member
Subject: Letter to File

This message was posted by a user wishing to remain anonymous

If you are introducing a new product under an already approved 510K, via letter to file, can marketing material state "FDA cleared"?  If so, what is the notification process to the FDA of the new product? Update Medical Device Listing?

If you truly have a "new" product which is completely covered by an existing 510(k), the correct mechanism of "notifying" FDA is to update your device listing and list the new device (and related UDI) under the current 510(k) number. Be sure you have robust documentation of why there is not a submitable change.

As for marketing materials saying "FDA cleared" generally FDA says you should not say this (they deem it misleading) even for the exact device to which the 510(k) applied. I'd think the risk is far too high in going further and trying to use this for a device that FDA hasn't even reviewed. The only exception I would make is in providing the original 510(k) letter and a summary of how it applies to the current device to customers who need it for their supply management systems.

Just IMO,

g-

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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 21-Aug-2019 17:06
From: Anonymous Member
Subject: Letter to File

This message was posted by a user wishing to remain anonymous

If you are introducing a new product under an already approved 510K, via letter to file, can marketing material state "FDA cleared"?  If so, what is the notification process to the FDA of the new product? Update Medical Device Listing?

Yes, I agree with you Ginger ... I take it back and corrected :).

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

Original Message:
Sent: 23-Aug-2019 10:35
From: Ginger Glaser
Subject: Letter to File

If you truly have a "new" product which is completely covered by an existing 510(k), the correct mechanism of "notifying" FDA is to update your device listing and list the new device (and related UDI) under the current 510(k) number. Be sure you have robust documentation of why there is not a submitable change.

As for marketing materials saying "FDA cleared" generally FDA says you should not say this (they deem it misleading) even for the exact device to which the 510(k) applied. I'd think the risk is far too high in going further and trying to use this for a device that FDA hasn't even reviewed. The only exception I would make is in providing the original 510(k) letter and a summary of how it applies to the current device to customers who need it for their supply management systems.

Just IMO,

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 21-Aug-2019 17:06
From: Anonymous Member
Subject: Letter to File

This message was posted by a user wishing to remain anonymous

If you are introducing a new product under an already approved 510K, via letter to file, can marketing material state "FDA cleared"?  If so, what is the notification process to the FDA of the new product? Update Medical Device Listing?