Booth videos for 510(k)-pending and investigational devices

Show season puts a lot of devices on the floor before they can be sold in the US. Some are waiting on a 510(k) decision. Some are still in a clinical study under an IDE. The booth loop for those products gets written the same way as every other loop, then gets stopped in review because nobody checked which rules apply to a device that isn't cleared yet.

The rules are older than most booth hardware, and they are short. This guide covers what FDA policy allows for a 510(k)-pending device and for an investigational device, what that means line by line for a booth video, and a checklist you can run on a script this week. If your team is exhibiting at RSNA 2026 (Nov. 29 to Dec. 3 at McCormick Place in Chicago, with technical exhibits open Nov. 29 to Dec. 2), there is still time to get this right.

Two different rules for two different statuses

"Not cleared yet" covers two situations that FDA treats differently. Sort your device into one of them before anyone writes a script.

Two edge cases matter. The CPG speaks only to pending 510(k)s, so a device with a pending PMA needs its own answer from your regulatory team. And if a 510(k) relied on an IDE study, a 1997 MD&DI column on display policy argued that the investigational rules likely take priority, so following them is the safer course. Ask your regulatory team which bucket your product is in, in writing, and put the answer at the top of the script.

What a booth video can show for a 510(k)-pending device

For a 510(k)-pending device, the video can show the product, how it works and the use you have asked FDA to clear. What it cannot do is invite a purchase. That sounds simple, but booth loops are written to drive conversations that end in a quote, so the sales language creeps in.

The CPG does not prescribe any wording for a pending device. The MD&DI column described "Pending 510(k), not available for sale within the United States" as wording FDA was considering at the time. Many teams still use a line like that because it tells a booth visitor the status in one read. We put it on screen whenever the product is visible, not only on the end card, because people walk into a loop at any second.

What changes for an investigational device

An investigational device is a different conversation. FDA's 1999 guidance on notices of availability of investigational devices (final, issued by CDRH) covers any notice made "through a notice, publication, display, mailing, exhibit, announcement, or oral presentation." A booth screen is a display, so it applies.

Under that guidance, a notice of availability should run only in medical or scientific publications or at medical or scientific conferences whose audience is mainly qualified experts. The content should be limited to four things:

• The proposed use of the device
• The name and address of the sponsor
• How to apply to be an investigator
• How to obtain the device for investigational use

The notice must also carry the caution statement, displayed prominently, in printing at least as large as the largest printing in the notice: "Caution: INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE." The device labeling rule in 21 CFR 812.5 uses the same caution and adds that labeling may not be false or misleading or state or imply that the device is safe or effective for the purposes being investigated.

Video has no "printing," so you have to translate that requirement. Our working reading, which your regulatory team should confirm: the caution appears on screen for the whole time the device or its proposed use is shown, and its type size is at least as large as the largest on-screen text in the loop. That rules out the common layout of a huge headline with a small caution in the lower third. It also tends to push investigational content toward a short, quiet loop rather than a full product film.

A worked example: one loop, two versions

Here is how we would storyboard a 45-second loop for a fictional company, Harbor Line Imaging, showing a fictional CT positioning accessory at a radiology meeting. Version A assumes the 510(k) is pending. Version B assumes the accessory is still in an IDE study.

Notice what Version B leaves out: no animation of results, no comparison to current practice, no "faster" or "safer." The 1997 column also noted that an earlier FDA guideline on investigational notices restricted price information, comparisons and volume discounts. Version B is short on purpose. If marketing wants more on screen, the answer is usually to wait for the decision, not to stretch the notice.

Plan for a fast swap. If the clearance lands before or during the show, you want a cleared version ready to load. We build pending loops with the status line, end card and claims on separate layers so the cleared version is a re-render, not a re-edit. That approach fits our trade show booth video work, and for a project like this one, custom motion graphics built from CAD sits at our Motion level, which starts at $3,200 (see pricing).

Script checklist for a pending or investigational booth loop

Run this on the script and again on the final render. It assumes the device status is already confirmed in writing.

1. Status at the top of the scriptWrite "510(k) pending (K number if assigned)" or "Investigational, IDE" on page one so every reviewer reads the same assumption.
2. Intended use matches the fileCopy the proposed use from the submission. Do not paraphrase it into something broader for the show audience.
3. Status or caution on screenPending: a clear status line whenever the device is visible. Investigational: the full caution statement, at least as large as the largest text, for the full loop.
4. No order pathNo prices, quotes, "reserve yours," shipping dates or QR codes that open a purchase or quote form.
5. No safe or effective claimsFor investigational devices, none at all. For pending devices, only claims your regulatory team ties to the submission.
6. Calls to action fit the statusDemo or scientific discussion for pending. Investigator inquiries for investigational.
7. Staff talk track matchesBooth staff say the same thing the screen says. A clean loop does not help if someone at the counter quotes a price.
8. Cleared version stagedA separate render with the status layer removed and approved claims added, reviewed in advance, ready if the decision arrives.

Both versions still go through your normal promotional review. Our guide on getting a device video through MLR review in fewer rounds covers how to package a script so reviewers can approve it quickly, and who regulates medical device ads and videos covers the FDA and FTC split once the device is cleared.

Practical timing for a show in five weeks

If you are reading this in late October with RSNA ahead, work backward from the first exhibit day. You need the status confirmed now, a script through review in the next two weeks, and a final render with time for one more review pass. A pending loop is usually simpler to approve than a launch film because it says less. Treat that as an advantage: a short, honest loop with clean visuals and a clear status line does its job at a booth, where many visitors see only part of the loop while walking past.

General information about FDA policy for displaying devices that are not yet cleared or approved. It is not legal or regulatory advice. Confirm your device's status and the right wording with your regulatory and legal teams.

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