What can a medical device startup say before and after FDA clearance?

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By Saroj Jha · November 2, 2026 · 15 min read

Before FDA clears or approves your device, you can tell the story of the company, the clinical problem, the team and the study, and you can show the device as investigational or “510(k) pending, not available for sale in the United States”. You cannot promote it, take orders, or say or imply that it is safe or effective for the use under study. After the decision, use the exact word on your FDA letter (cleared, granted or approved), quote the indication for use word for word, and keep every claim inside it, because FDA reads what a device is for from everything you say. If you sell to consumers, the FTC’s evidence standard for health claims applies on top. Plan the wording now, and have your regulatory adviser sign it off.

Here is what each stage allows, in the order a startup meets it.

Running case: Example Co. Fictional

Example Co. is a fictional seed-stage company with a wearable nerve stimulator for knee osteoarthritis pain, to be sold over the counter to consumers and through physical therapy clinics. FDA received its 510(k) on 1 February 2027 and accepted it for review. The team wants a waitlist page, a conference booth, a founder post and an investor update before the decision, and a consumer launch after it. Its marketing lead has drafted 14 lines of copy for those assets. Example Co., its device and its dates are fictional.

Why does every public sentence count before clearance?

Because FDA decides what a device is intended for from what the company says, not only from the label. The regulation defines intended uses as “the objective intent of the persons legally responsible for the labeling”, and lists “labeling claims, advertising matter, or oral or written statements” by those persons or their representatives as ways that intent is shown^[3]. A website, a pitch deck read by the public, a booth banner and a founder’s post all count.

Both regulators act on device advertising. GAO reported that FDA took 255 enforcement actions related to medical device advertising issues between 2018 and 2022, and the FTC 67 public enforcement actions over the same period^[2]. GAO’s count of enforcement actions includes advisory actions such as warning letters as well as administrative and judicial actions, and both figures come from the agencies’ officials, with no breakdown by type^[2].

In my view, the practical rule is simple: a sentence you would not put in your regulatory submission should not appear in public either. AAJ’s report on clinical evidence in device marketing covers what evidence each kind of claim needs; this post is about timing and wording.

Do this

Collect every public asset that mentions your device (site, deck, posts, booth copy, recruiting ads) into one folder, so that one reviewer can read them together before anything new goes out.

What does FDA forbid while the device is investigational?

While a device is under clinical investigation, FDA’s rule sets four limits on the sponsor, investigators and anyone acting for them. They may not “promote or test market an investigational device, until after FDA has approved the device for commercial distribution”; charge more than is needed to recover the costs of manufacture, research, development and handling; unduly prolong the investigation; or “represent that an investigational device is safe or effective for the purposes for which it is being investigated”^[4]. The device’s label must carry the statement “CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use”, and its labeling may not be false or misleading^[5].

The device rule is stricter in one way that surprises founders who know the drug rules. The parallel rule for investigational drugs says it “is not intended to restrict the full exchange of scientific information concerning the drug”, including findings shared in scientific or lay media^[6]. The device rule has no such sentence^[4]. In my view, that means study results presented before clearance should be factual, labelled as investigational, and free of any statement that the device works.

Recruiting is allowed, inside rules. FDA’s guidance on notices of availability says a notice to recruit investigators may describe the proposed use, the sponsor and how to apply, must state that its purpose is only to obtain investigators, and must not call the device “reliable, durable, dependable, safe, or effective” or compare it with other devices^[7]. Ads to recruit study participants go through the IRB and should avoid implying safety or effectiveness, using “new treatment” without saying the device is investigational, or promising “free medical treatment”^[7].

Example Co., step 1 Fictional

Example Co.’s recruiting ad for its home-use study first read “A new drug-free treatment for knee pain, free for participants”. The revised ad, sent to the IRB, reads “We are looking for adults with knee osteoarthritis pain to take part in a study of an investigational wearable device. Participants will be paid for their time.” The device photo stays; the words “treatment” and “free” go.

Do this

Read every study-related line you publish against the four limits in 21 CFR 812.7 and strike any word that says or implies the device works.

What can I publish before clearance?

More than founders expect, as long as it is about the problem and the company rather than a product for sale. In my view, five things are usually safe with regulatory review: the company story and mission, the clinical problem and its burden (with sources), the team and advisers, the existence and design of your study, and investor and scientific communication that states the device is investigational. My post on telling a founder story without overpromising covers the first.

Showing the device is also possible. FDA’s compliance policy on 510(k)s says a firm “may advertise or display a device that is the subject of a pending 510(k)”, but “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”^[8]. That is the basis for the familiar booth sign “510(k) pending, not available for sale in the United States”. A waitlist that collects interest is different from a pre-order page that takes payment or commits a buyer, and in my view only the first is compatible with that policy.

The safe topics stop being safe when they carry a claim. “Knee pain affects millions of adults” is a statement about a problem; “a drug-free way to end knee pain” is a claim about your device, even with no product name in the sentence. Investor decks that are posted publicly, conference abstracts and founder posts are read by the same people as your website.

Example Co., step 2 Fictional

Example Co.’s regulatory adviser sorts the 14 draft lines. Six can go out now: the mission, the problem with a cited source, the team, the study design, an investigational device photo with the 510(k) pending statement, and a waitlist that takes an email address and nothing else. Five wait for the decision, including the price and “order now”. Three can never run on this clearance, including “safer than pain pills”. That is 6 of 14 (43%) now, 5 (36%) after clearance and 3 (21%) never.

Do this

Sort every draft line into “publish now”, “after the letter” and “never”, and have your regulatory adviser sign the sort.

What do cleared, granted, approved and authorized mean?

They name different FDA decisions, and the word you use is itself a claim. A 510(k) shows that a device is substantially equivalent to a legally marketed device, and FDA’s order “clears” it for commercial distribution^[9]. A De Novo request is for a device with no legally marketed predicate; when FDA grants it, “the new device is authorized to be marketed” and can become a predicate for later 510(k)s^[10]. Premarket approval is “the most stringent type of device marketing application”, for class III devices, and “PMA approval is based on a determination by FDA” that the evidence assures safety and effectiveness^[11].

In my view the specific word on your letter is clearer than a general one such as “authorized”. The one word you cannot borrow is “approved” for a 510(k): the regulation says a substantial equivalence finding “does not in any way denote official approval of the device”, and that representing a device as officially approved because of it is misleading and misbranding^[12]. The FTC makes the same point from the advertising side: an example in its guidance describes infomercials for an ab belt cleared as a class II device as deceptive, because they paired “FDA Approved” with weight-loss claims and so implied FDA had found it effective for those results^[13].

My rule of thumb, not a benchmark: write the status in the words of your letter, and never place it in the same sentence as an outcome claim. The MedTech Marketing Playbook sets out the word for each route in its claims step.

Example Co., step 3 Fictional

The draft launch banner read “FDA approved knee pain relief”. After review it reads “Example Co. is FDA cleared” in the footer, and the headline describes the indication without the status beside it.

Do this

Search your site and deck for “approved”, “certified” and “FDA-backed”, and replace each with the word on your letter.

After clearance, how far can my claims go?

As far as your indication for use, and no further. FDA’s 2018 guidance on communications consistent with labeling says that, for its purposes, such information “is limited to information about the approved or cleared uses of a product”^[14]. Quote the indication word for word in the places where you describe what the device does, and build benefit lines from it rather than from what users tell you they do with it.

A new use needs a new decision, not new copy. FDA’s rule requires a new premarket notification for “a major change or modification in the intended use of the device”^[1]. Because intended use is read from your statements^[3], marketing a device for a use outside its clearance can turn a cleared device into one being marketed without the clearance that use needs.

Clinicians may use a legally marketed device off-label; the law says nothing in it limits a practitioner’s authority to prescribe or administer one for any condition within a legitimate practitioner-patient relationship^[15]. That freedom belongs to the clinician, not to your sales team. FDA’s January 2025 guidance on sharing scientific information about unapproved uses with health care providers is final, but its page says it is “not for current implementation” pending the Office of Management and Budget’s decision^[16]. In my view, until it takes effect, route every off-label question to a trained medical or regulatory person who answers in writing.

Example Co., step 4 Fictional

The clearance letter (in this fictional case) covers temporary relief of pain associated with knee osteoarthritis, for adults, over the counter. Physical therapists start asking about use after knee replacement surgery. That line is logged in the claims table as outside the indication, sales are told to pass the question to the regulatory lead, and the founder asks the adviser whether a new 510(k) would be needed for it.

Do this

Paste your indication into the top of your claims table, and mark every claim as inside or outside it before launch.

What changes when I market to consumers?

A second regulator’s test applies. The FTC Act makes it unlawful to disseminate a false advertisement likely to induce the purchase of “food, drugs, devices, services, or cosmetics”, and treats it as an unfair or deceptive practice^[17]. GAO reports that the FTC has primary responsibility for the truth or falsity of advertising for devices that are not restricted, which includes most over-the-counter devices, while FDA has primary responsibility for restricted devices^[2].

The FTC’s evidence bar for health claims is high. Its Health Products Compliance Guidance applies to “any health-related product”, names health equipment, diagnostic tests and health apps, and says that, as a general matter, “substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing”^[13]. FDA clearance does not by itself substantiate an ad claim, and the guidance warns advertisers not to “mischaracterize or overstate any FDA assessment of the science supporting a particular claim”^[13].

For consumer marketing, testimonials and reviews follow the FTC’s endorsement rules; my post on privacy and advertising rules for startup marketers covers those, and the legal basics of a startup marketing site covers the site itself. I will not repeat them here.

Example Co., step 5 Fictional

The consumer ad draft says “works in 10 minutes”. The only data is a 30-person study without a control group, so the line goes back to the claims table until a controlled study supports it. The ad runs with the indication and a “how it works” explainer instead.

Do this

For every consumer ad claim, write the study that supports it next to it; if the study is not a controlled human study in the cleared population, rewrite the claim.

How do I plan the switch from pre-clearance to launch?

Plan it as a date you do not control. A 510(k) must be submitted at least 90 days before the device is introduced into interstate commerce^[1], and FDA’s goal under MDUFA V is a decision on 95% of 510(k) submissions “within 90 FDA Days”^[18]. FDA days count only while the submission is under review; an Additional Information letter stops the review clock until you answer^[18].

So prepare both sets of copy in advance. Keep the pre-clearance set live until the letter arrives, draft the post-clearance set with a blank for the 510(k) number, and swap them only when your regulatory adviser has signed the final sentence. The MedTech playbook’s step on announcing the clearance covers the launch assets themselves.

Example Co., step 6 Fictional

The review clock runs for 60 FDA days, then FDA sends an Additional Information letter on 2 April 2027. Example Co. answers on 16 June, 75 days later, and the clock restarts. FDA decides 30 FDA days later, on 16 July: 90 FDA days, but 165 calendar days after FDA received the submission (60 + 75 + 30). The waitlist page and the investigational booth copy stay up until that day; the launch site, priced and with “order now”, goes live once the cleared sentence is signed.

Do this

Write down the date FDA received your submission and keep two versions of every asset, pre-clearance and post-clearance, ready to swap on the day the letter arrives.

This is orientation, not legal advice.

What changes by stage?

• Pre-seed — Talk about the problem and the company, never the product’s performance. Get a regulatory adviser to read your deck before it goes anywhere public.
• Seed — Run the study under the investigational rules, send recruiting ads through the IRB, and build the claims table and both sets of copy before you submit.
• Series A–B — Give one person sign-off on every public claim, train sales on off-label questions, and add an evidence plan for any new indication before marketing plans assume it.

Free tool

Flag every sentence that needs proof before it goes out

The free Claims and Proof Checker flags each sentence in your site, deck or ad copy that states an outcome, a population, a comparison or a number, so you know which lines need evidence and regulatory review before they go out.

For the evidence behind each kind of claim, read AAJ’s report on clinical evidence in device marketing; for the full launch sequence, from the claims table to the clearance announcement, use the MedTech Marketing Playbook. If hospitals are your buyer, how US hospitals buy medical devices explains who reads your claims there.

If you want me to look at your own funnel, positioning and channels, my Growth Audit ends with three prioritized fixes and a 30-day action plan.