Regulatory Open Forum

Hello-

We are planning on submitting a 510k early 2020 for our Class II device. This is a non-active device, transient use with intact skin only. We have similar devices currently on the market but with the change we are required to submit a new 510k.  I know FDA has released guidance for labeling requirements while the 510k is currently under review but I have not found any solid guidance for how to label/market prior to submission. Some sources say it is fine as long as there is clear text indicating it is not available for sale/under development and other sources say you can't speak about it at all. Can someone point me in the right direction for guidance on this?

Thanks!

Promotion is allowed by FDA only under the following conditions, when a 510(k) is pending:

See CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) of September 1987 concerning the promotion of devices that are the subject of a pending 510(k). This CPG states that "a firm may advertise or display a device that is the subject of a pending 510(k)" application, but that it "may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use"
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-300600-commercial-distribution-regard-premarket-notification-section-510k

 The CPG prohibits the commercial sale, solicitation or taking of orders for a device that is subject to a pending 510(k). Even if you would like to make use of the above provision, the labelling of the device should clearly show that the device is not available for sale in U.S.A. If investigational device, this should be also clearly stated in the materials, as provided by FDA. Also, you cannot make any safety, effectiveness, performance claims about the device.

Hello-

We are planning on submitting a 510k early 2020 for our Class II device. This is a non-active device, transient use with intact skin only. We have similar devices currently on the market but with the change we are required to submit a new 510k.  I know FDA has released guidance for labeling requirements while the 510k is currently under review but I have not found any solid guidance for how to label/market prior to submission. Some sources say it is fine as long as there is clear text indicating it is not available for sale/under development and other sources say you can't speak about it at all. Can someone point me in the right direction for guidance on this?

Thanks!

Promotion is allowed by FDA only under the following conditions, when a 510(k) is pending:

See CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) of September 1987 concerning the promotion of devices that are the subject of a pending 510(k). This CPG states that "a firm may advertise or display a device that is the subject of a pending 510(k)" application, but that it "may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use"
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-300600-commercial-distribution-regard-premarket-notification-section-510k

 The CPG prohibits the commercial sale, solicitation or taking of orders for a device that is subject to a pending 510(k). Even if you would like to make use of the above provision, the labelling of the device should clearly show that the device is not available for sale in U.S.A. If investigational device, this should be also clearly stated in the materials, as provided by FDA. Also, you cannot make any safety, effectiveness, performance claims about the device.

Hello-

We are planning on submitting a 510k early 2020 for our Class II device. This is a non-active device, transient use with intact skin only. We have similar devices currently on the market but with the change we are required to submit a new 510k.  I know FDA has released guidance for labeling requirements while the 510k is currently under review but I have not found any solid guidance for how to label/market prior to submission. Some sources say it is fine as long as there is clear text indicating it is not available for sale/under development and other sources say you can't speak about it at all. Can someone point me in the right direction for guidance on this?

Thanks!