Hi Lee et al,
I do agree with your assessment. The information I am providing comes from the following references:
CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (July 1978);
FDA, Guidance for Industry: Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers (June 2018);
FDA/CDRH "Guideline for Preparing Notices of Availability of Investigational Medical Devices" (March19, 1999).
Please note: Each situation is unique, so I encourage you to consult with Reg/legal when evaluating whether a specific communication may be appropriate. This information is strictly for all premarket communications for 510(k) devices:
Do not take orders or prepare to take orders that may result in contracts for sale. Do not make promises of FDA clearance or exact date for FDA clearance (note that high-level information related to anticipated timeline is permitted such as "we anticipate FDA clearance this year."
• Do not promote, commercialize or test market the device.
• Do not represent that the device is safe or effective (e.g., cannot say "it will increase accuracy to help with diagnosis").
• Do not make comparative claims (e.g., device will be the "standard of care", "gold standard") or claims about device performance or clinical benefit ("e.g., designed to reduce [X] adverse event or improve patient outcomes"). Note that the use of the term "designed to" does not reduce the risk associated with claims that are not otherwise permitted.
• Information provided must be non-promotional, unbiased, factual, truthful, and non-misleading, in substance and tone.
Make clear the stage of product development (i.e., "510(k) pending" or "510(k) submission planned") and that the product is "not for sale in the U.S." and that the safety and effectiveness of the product has not been established.
Guidelines for Pre-market communications at Trade Shows (example below):
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[Monica] [Montanez] [MS RAC CQA]
[Principal Regulatory Affairs Specialist]
[NAMSA]
[Bailey [Colorado]
[USA]
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Original Message:
Sent: 17-Sep-2021 06:53
From: Lee Leichter
Subject: Vaporware or prototypes at trade shows PRIOR to a 510k being submitted?
Victor,
This is one time that is seems that I must disagree with you.
There are only two states of a device 510(k) eligible (or any other) device – unapproved or cleared/approved. It is my interpretation that you can display, but not take orders, etc. for any unapproved device, regardless as to whether it has been submitted or not. The restriction from displaying or discussing devices that are under development, but not yet submitted is more about free speech. The omission that the product is not yet approved (which includes not submitted, not accepted, not reviewed, or otherwise investigational) and the taking of orders, or being prepared to take orders, that might result in contracts of sale for the device is the prohibition.
A company should not, and I believe cannot be prohibited form displaying a prototype device, or showing future plans for a "yet-to-be-developed device, as long as it is clear as to the regulatory status, and they do not take orders. I would caution companies as to the wording of that status (e.g. stating that a 510(k) has been submitted before it has been accepted, I would suggest "Not approved for use in the USA before acceptance of the 510(k)) but otherwise suggest it is acceptable to discuss.
Lee
Original Message:
Sent: 9/16/2021 2:01:00 PM
From: Victor Mencarelli
Subject: RE: Vaporware or prototypes at trade shows PRIOR to a 510k being submitted?
Hi Anon.
I have always read this to be rather specific. A company, per the CPG, would be allowed to advertise or display the device assuming that you have the 510(k) submitted and it is pending review before the agency. Even in that situation you can't be taking orders or working towards contracts for sales other than for research or investigational use because that would be sale of an unapproved medical device.
In your situation you stated that you haven't submitted the 510k as yet. To me, the CPG is fairly specific here - the allowance attaches only after the 510k is submitted and accepted for review. I would not be comfortable with display of prototypes or even discussion of the product before you submit your 510k and are informed that the submission has passed the FDA validations for further substantive review by the agency.
That is just my opinion and obviously others can certainly disagree. Honestly if someone knows of any other resources that would make my reading inaccurate I would truly love to know about that too!
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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
Original Message:
Sent: 15-Sep-2021 15:58
From: Anonymous Member
Subject: Vaporware or prototypes at trade shows PRIOR to a 510k being submitted?
This message was posted by a user wishing to remain anonymous
Hi all,
I see that the the FDA has this guidance: CPG Sec. 300.600 Commercial Distribution, Premarket Notification states "Although a firm may advertise or display a device that is the subject of a pending 510(k) -- in the hope that FDA will conclude that the device is substantially equivalent to a pre-amendments device -- a firm 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."
However, I can't seem to find guidance from the FDA about showing prototypes or discussing vaporware PRIOR to a 510k being submitted.
Thoughts?