Medical Device Promotional Review: What a Promo Piece Needs Before It Ships

Bottom line: Every claim on a medical device promotional piece has to stay consistent with the

device's cleared or approved indications for use, and every claim needs substantiation the company

can produce on request. Before the piece ships, three things should exist in writing: the exact

indication language the piece maps to, the evidence behind each performance claim, and a dated

sign-off from whoever owns regulatory review. Most device companies get the first two roughly

right and have no defensible answer for the third.

This is a primer, not legal or regulatory advice. Run every piece through your own regulatory affairs and legal teams before release.

This guide is written for the marketer holding the piece. It assumes you have a finished brochure, a booth panel, a landing page, a product video, or a sales deck, and you need to know what has to be true about it and who signs it. It does not cover how to get a device cleared. If your question is about submission pathways rather than promotion, start at the FDA-compliant marketing module instead.

The Rule That Governs Everything

There is one rule underneath all of this, and every other rule in this guide is a consequence of it.

What you say about a device defines what the device is for. Under 21 CFR 801.4, a device's intended use is established by the objective intent of the people who market it, and FDA looks at the circumstances surrounding distribution to determine that intent. Labeling claims, advertising, and oral or written statements by the firm or its representatives all count. So a claim is not just a marketing decision. A claim that reaches past the cleared indication is evidence that the device has an intended use the agency never evaluated.

The consequence is misbranding, and it arrives by two separate routes. Section 502(a)(1) of the Federal Food, Drug, and Cosmetic Act provides that a device is misbranded "if its labeling is false or misleading in any particular." Section 502(f)(1) separately requires labeling to bear adequate directions for use. Prescription devices generally rely on the exemption from 502(f)(1) at 21 CFR 801.109, and that exemption is conditional: 801.109(c) and (d) require the labeling to carry adequate information for the licensed practitioner, including indications, hazards, contraindications, side effects, and precautions, covering "all purposes for which it is advertised or represented." So a claim that reaches past the authorized indication can make the labeling misleading under 502(a)(1), and it can also pull the device outside the 801.109 exemption its labeling depends on.

The current text of 21 CFR 801.4 comes from FDA's final rule "Regulations Regarding 'Intended Uses'," 86 FR 41383, published August 2, 2021 and effective September 1, 2021, which amended 21 CFR 201.128 for drugs and 21 CFR 801.4 for devices.

Where the authoritative indication text actually lives

Marketers routinely write from an internal one-pager that has drifted from the cleared language. The authoritative text is not the one-pager. It is the document your marketing authorization produced.

Two things fall out of that table that get companies in trouble constantly. A 510(k) device is never "FDA approved," and under 21 CFR 807.97 any representation that creates the impression of official approval because the device complied with premarket notification is misleading and constitutes misbranding. Separately, under 21 CFR 807.39, establishment registration does not denote approval or endorsement either, so a registration number is not a marketing credential. If the difference is still fuzzy on your team, the longer treatment is at FDA cleared vs FDA approved.

Consistent with the labeling is a defined term, not a vibe

FDA's guidance "Medical Product Communications That Are Consistent With the FDA-Required Labeling (Questions and Answers)" (final guidance, June 2018, docket FDA-2016-D-2285) is the document to read if you read only one. It is a nonbinding guidance, and it is still current.

It sets out three factors FDA uses to decide whether a communication is consistent with the FDA-required labeling. The guidance states that if a communication fails any one of the three, it is not consistent with the labeling.

1. How the information in the communication compares to the labeling's conditions of use, across four named areas: indication, patient population, limitations and directions for handling or use, and dosing or use regimen and administration.
2. Whether the communication increases the potential for harm to health relative to what the FDA-required labeling reflects.
3. Whether the directions for use in the FDA-required labeling enable the product to be used safely and effectively under the conditions the communication represents or suggests.

Note what is not in that list. Evidentiary support is a separate requirement, not the third factor. The guidance handles it under a different question, and its standard is that data, studies, or analyses relied on should be "scientifically appropriate and statistically sound." A communication can clear all three consistency factors and still be false or misleading for other reasons.

The part most device marketers miss: the three factors are not the test for most devices. The CFL guidance says FDA does not analyze communications about 510(k)-cleared and 510(k)-exempt devices under those factors. For a 510(k) device, the operative question is whether the communication would trigger the need for a new 510(k), assessed under FDA's guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device" (October 2016). The CFL guidance is explicit that FDA views communications that trigger the need for a new 510(k) as inconsistent with the FDA-required labeling, and communications that do not trigger one as consistent with it. For 510(k)-exempt devices, the analysis runs against the limitations of exemption at 21 CFR 862.9 through 892.9. The three-factor test is the framework for PMA and De Novo products and for drugs and biologics.

The practical translation for a marketer working on a 510(k) device is that the question to put to regulatory is not "does this feel consistent," it is "would this claim, if we submitted it, require a new 510(k)." That is a question the regulatory lead can actually answer against a written standard, and it is a much better prompt than asking someone to eyeball a brochure.

Is your piece labeling, or is it advertising?

This determines who owns the piece and how hard it is to change later, and most marketing teams never ask it.

Labeling covers the label on the device and the written, printed, or graphic matter accompanying it, and it can reach promotional pieces that are textually related to the device and distributed with it. Labeling is a design output. Under the Quality Management System Regulation, which took effect on February 2, 2026, design and development requirements sit at 21 CFR 820.10(c), which requires manufacturers of class II, class III, and certain listed class I devices to comply with ISO 13485:2016 Clause 7.3, and FDA's supplemental device labeling and packaging controls provision sits at 820.45. If the piece is labeling, it is a controlled document, and marketing does not revise it alone. The old 21 CFR 820.30 design controls section is reserved under the QMSR, so a review SOP that still cites 820.30 as its regulatory basis is out of date. Background on that transition is at the QMSR transition and the design history file.

Advertising sits outside the labeling definition and follows a lighter internal path, though it is still subject to the misbranding rules above, to substantiation standards, and to competitor challenges. The statute draws the line itself: section 502(r) ends by saying it does not apply to printed matter that FDA determines to be labeling as defined in section 201(m). Labeling status and advertising status are mutually exclusive for a given piece, and FDA gets to make the call.

The one fact that changes the whole advertising analysis: is your device restricted?

Most people on the marketing side assume device advertising is FTC territory and device labeling is FDA territory. That is roughly right for most devices and completely wrong for restricted devices, and the status is invisible unless someone looks it up.

A restricted device is a device that FDA has restricted, by regulation, as to sale, distribution, or use under section 520(e) of the FD&C Act, 21 U.S.C. 360j(e). The statute is explicit: "A device subject to a regulation under this subsection is a restricted device." A restriction can also be imposed as a condition of PMA approval under section 515(d)(1)(B)(ii), which is the mechanism 21 CFR 814.82(a)(1) implements. So the way to answer the question for a specific device is to read its classification regulation and, for a PMA product, its approval order. It is not a judgment call a marketer should make from the outside, and it is worth noting that whether prescription status alone makes a device restricted has never been cleanly settled, which is exactly why this belongs with regulatory rather than with marketing.

If the device is restricted, two additional provisions attach to advertising, not just labeling:

• Section 502(q) makes a restricted device misbranded if its advertising is false or misleading in any particular, or if it is sold, distributed, or used in violation of the 520(e) regulations.
• Section 502(r) requires every advertisement and other descriptive printed matter to carry the device's established name, printed prominently and in type at least half as large as any trade or brand name, plus a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications.

Two things in 502(r) are worth knowing because they get stated backwards constantly. First, FDA does not pre-approve advertising: the same paragraph says that except in extraordinary circumstances, no regulation issued under it shall require prior approval of the content of any advertisement. Anyone who tells you FDA approved an ad is describing something that did not happen. Second, the FTC carve-out is real but narrow. Advertising of a restricted device is not subject to sections 52 through 55 of title 15, the FTC Act's false advertising provisions, with respect to the matters specified in 502(r) or covered by regulations issued under it. That is a carve-out for those specific matters, not a general exit from FTC jurisdiction, and it is a bad idea to read it as one.

For devices that are not restricted, FDA's authority runs to labeling and to the intended use consequences described above, while advertising practice is governed primarily by the FTC Act. FDA states its own scope the same way: in the CFL guidance, FDA describes the truthful and non-misleading requirement as applying to "labeling for drugs and devices and advertising for prescription drugs and restricted devices," citing sections 201(n), 502(a), 502(n), 502(q), and 502(r). Note that the older description of this split as a matter of interagency understanding is not the useful reference point. The statute is, and the statute is what a reviewer can hand to a skeptical stakeholder.

Ask the labeling-or-advertising question early. Reclassifying a piece as labeling after it is designed usually means a round trip through document control that nobody budgeted for.

Who Reviews What, In What Order

Large pharmaceutical companies run promotional material through MLR, a standing medical, legal, and regulatory committee. Most device companies do not have one. A twelve-person medtech company has a regulatory consultant, a founder who used to be a rep, and a marketer who inherited the brochure folder. That is the situation this section is written for.

You do not need a committee. You need a fixed order, a named owner at each step, and a record.

Four notes on running this when the team is small.

One person can hold more than one step, but no person holds step 1 and step 6. The marketer who wrote the piece is not the approver. That single separation is most of the value of a formal review function, and it costs nothing to implement.

The claims matrix is the whole workflow. It is a two-column list: the claim exactly as it appears on the piece, and the document that backs it. If a claim has no document, it is not a claim, it is a sentence you liked. Build it before review starts, not during. Reviewers who are handed a finished PDF and asked to "take a look" will approve things they would have questioned in a list.

Archive the substantiation, not just the artwork. The failure mode is not the review, it is the question two years later about what supported line four of a brochure nobody kept a source file for. Three separate retention obligations can land on a promotional file, and marketers usually know about none of them.

The one that names advertising directly is 21 CFR 807.26, part of the establishment registration and device listing rules. It requires each owner or operator to maintain a historical file of labeling and advertisements. The contents depend on the device: for a restricted device, a copy of all labeling and all advertisements; for a device subject to section 514 or 515 that is not restricted, a copy of all labeling; for everything else, labels, package inserts, and a representative sampling of other labeling. Paragraph (b) adds anything in which a material change was made after initial listing. Paragraph (c) sets the floor for how long: material may be discarded three years after the date of the last shipment of a discontinued device. And paragraph (e) is the part that makes it real, because FDA can request the file, including a representative sampling of advertisements for a restricted device and, for good cause, all of them.

The second is the quality system. If the piece is labeling, it is a QMS record, and record control under the QMSR runs through 21 CFR 820.35, which builds on ISO 13485:2016 Clause 4.2.5, Control of Records. So yes, Clause 4.2.5 is the right thing to cite, but cite it the way the QMSR reaches it, through 820.35 and the incorporation by reference at 820.7, rather than as a free-standing ISO requirement.

The third is substantiation, which has no fixed clock. FTC's expectation is that a company can produce its support at the time the claim is made and for as long as the claim runs. In practice, the workable rule is to retain the approved artwork, the claims matrix, and every source document together for the life of the claim plus the 807.26 tail, and to treat the retirement of a claim as an archiving event rather than a deletion event.

A note for anyone who came from pharma. There is no device equivalent of Form FDA 2253. The routine submission of promotional materials to FDA at time of first use is a prescription drug and biologic obligation, and devices have nothing like it. What devices have instead is the 807.26 historical file: keep it, keep it retrievable, and be able to produce it when asked. That is a lower day-to-day burden and a higher retrieval burden, which is exactly the combination that punishes teams who archive the finished PDF and nothing else.

Fix the sequence, not the calendar. Regulatory before clinical wastes clinical's time on claims that will not survive. Legal before regulatory wastes legal's time entirely. Design freeze before review means every comment becomes a layout problem, which is how good comments get talked out of the room. Review the copy first, then design it.

The Claim Substantiation Table

Print this one. It is the fastest way to run a real piece: read one claim, find its row, ask whether you have the thing in column two, and note where it lives in column three.

Two rules that apply to every row.

The evidence has to match the audience and the population. A study in adults does not support a claim aimed at pediatric use. A bench test does not support a clinical outcome claim. A claim supportable to a payor audience under the June 2018 payor communications guidance is not automatically supportable in a booth panel read by a surgeon.

FTC's substantiation standard generally applies to advertising alongside FDA's rules. For health-related claims, FTC staff expects competent and reliable scientific evidence, set out in the FTC's Health Products Compliance Guidance (December 2022), which updated and replaced the 1998 dietary supplement advertising guide. A device company can satisfy FDA on the indication and still face an FTC problem, a state attorney general, or a competitor's Lanham Act suit over how the evidence was characterized. The one qualifier: as noted above, section 502(r) carves restricted device advertising out of FTC Act sections 52 through 55 with respect to the matters 502(r) covers, so for a restricted device the allocation between the two agencies is not the default one and is worth confirming rather than assuming. Competitor challenges, including through the National Advertising Division of BBB National Programs, move faster than either agency does and are the more likely first contact for an aggressive comparative claim.

Where Marketers Step Over the Line

These are the recurring ones. None of them require bad intent, and most of them start as a reasonable-sounding edit late in the process.

Promoting past the indication. The indication says one anatomy, one patient population, one procedure. The brochure headline says the category. Widening happens in the headline more often than in the body, because headlines get rewritten after review for punch. Re-review any headline changed after regulatory sign-off.

One reason this particular error is worth more attention than its frequency suggests: promotion outside the authorized indication is not only an FDA exposure. It is the standard factual predicate for False Claims Act cases built on the theory that the resulting claims to federal health care programs were not payable, and it frequently travels with Anti-Kickback Statute allegations at 42 U.S.C. 1320a-7b when the promotion ran through paid physician relationships. That is a different category of consequence than a warning letter, and it is the reason a company's compliance officer tends to care about the brochure more than the marketing team expects.

Calling a cleared device approved. Covered above, and it is the single most common device marketing error. It also shows up as "FDA registered," "FDA certified," and "FDA listed," none of which are marketing authorizations. See 21 CFR 807.39 and 21 CFR 807.97.

Promoting a designation as if it were an authorization. Breakthrough Device designation, participation in a pilot program, and grant funding are not findings of safety or effectiveness. Breakthrough designation is granted under section 515B of the FD&C Act, 21 U.S.C. 360e-3, and what it buys is interactive review and prioritization, not a conclusion about the device. FDA's Breakthrough Devices Program guidance (final, September 2023) says the eligibility considerations "are different from and do not change the statutory requirements for safety and effectiveness to support a marketing authorization."

Worth being straight about the state of the record here: FDA has not published guidance specifically on how a designation may be referenced in promotion. There is no safe-harbor phrasing to copy. What governs is the same misleading-impression logic that sits behind 21 CFR 807.97, so the framing that survives review is the one that states the designation as a program status with a date, keeps it away from any efficacy or approval language, and does not let it modify a performance claim. "Designated a Breakthrough Device by FDA in [year] for [the designated indication]" is a statement of fact about a program. The same designation dropped next to an outcome claim, or compressed into a badge that reads as an endorsement, is doing different work. Companies with a designation should get their exact wording approved by their regulatory lead once and then reuse it verbatim everywhere, rather than letting each piece paraphrase it.

Promoting before authorization. 21 CFR 812.7 is worth reading rather than paraphrasing, because the common shorthand is imprecise. It prohibits a sponsor, investigator, or anyone acting for them from promoting or test marketing an investigational device until after FDA has approved it for commercial distribution; from commercializing it by charging subjects or investigators more than what is needed to recover the costs of manufacture, research, development, and handling; from unduly prolonging an investigation; and from representing that the device is safe or effective for the purposes for which it is being investigated. The charging clause is a cost-recovery limit, not a blanket ban on any money changing hands, and getting that wrong in either direction causes real confusion internally. Investigational labeling requirements sit at 21 CFR 812.5.

The work that fits in that window is real but narrow, and it is mostly work that is not about the device's clinical performance: building the site and the sales infrastructure, describing the company and the technology platform, IRB-approved trial recruitment, and market research. The line teams cross is describing clinical benefit.

Superiority without head-to-head data. "Better outcomes" built from two separate single-arm studies is not a comparison, it is two studies next to each other. This is where competitors sue.

Selective presentation. Showing the endpoint that hit and omitting the one that did not, quoting a subgroup without saying it was a subgroup, or dropping the confidence interval because it did not fit the layout. "Fair balance" is a term of art from the prescription drug advertising rules at 21 CFR 202.1 and does not transfer to devices as a formal requirement, so avoid using it as though it does. The device-side exposure is more basic and reaches further: an incomplete or misleading data presentation can make labeling false or misleading under 502(a)(1) on its own, and for a restricted device it can do the same to advertising under 502(q).

Professional-use devices promoted to patients. If the labeling is for use by a trained clinician, consumer-facing copy that positions the device as something a patient chooses or uses is a different intended use than the one that was cleared.

Importing claims across markets. A claim supported by a CE mark under EU MDR is not supported in the United States, and the reverse is equally true. One global brochure with the union of all markets' claims is a violation in every one of them. Gate by market. That requirement is a website architecture problem as much as a copy problem.

Sales building their own slides. A rep's homemade deck carries the same regulatory weight as the corporate brochure, because 21 CFR 801.4 counts statements by the firm's representatives as evidence of intended use. Give the field an approved library that is genuinely good enough to use, and audit what is actually in circulation. Warning letter patterns in this area are worth reading: FDA warning letters on device marketing claims.

One clarification about who is on the other side of this. Drug promotion has a dedicated FDA office, the Office of Prescription Drug Promotion in CDER, and its letters get most of the press. Devices do not have a counterpart. Device promotional issues are handled inside the Center for Devices and Radiological Health, principally through its Office of Product Evaluation and Quality, and device warning letters are issued in the Center's name rather than by a named promotion office. The practical consequence is that device promotional problems usually surface bundled with something else, most often an inspection finding, a device change that should have had a new 510(k), or a quality system observation, rather than as a standalone advertising review. Anyone benchmarking device risk against published drug promotion enforcement is reading the wrong dataset.

Digital-Specific Traps

Digital promotion carries every rule above plus a set of failure modes that print does not have.

Character-limited platforms. Space constraints do not reduce the obligation to present benefit and risk information appropriately. FDA addressed this in "Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices," docket FDA-2014-D-0397. It was issued in June 2014, it remains a draft that FDA has never finalized, and it is still the only FDA document that speaks directly to paid search ads. It has not been superseded. Treat it as FDA's stated thinking rather than as a rule, and note that its scope is explicitly prescription drugs and devices, and explicitly includes online paid search alongside microblog posts. It does not reach product websites or web banners, which FDA says do not carry the same constraints.

Three things in it are worth carrying into a media brief. If a firm makes a benefit claim, the risk information belongs in the same communication rather than behind the click. Any link offered for risk information should go to a landing page devoted exclusively to risk, because FDA says a link to a product home page that also carries benefit claims does not qualify. And the guidance's own backstop is the most useful sentence in it: if an accurate and balanced presentation of both risks and benefits is not possible within the platform's constraints, the firm should reconsider using that platform. If a benefit claim does not fit alongside its qualifying information, the answer is usually a different creative approach, not a smaller qualifier.

Paid social targeting. Ad networks apply their own healthcare policies on top of FDA rules, and a device ad is more often rejected for its targeting or its landing page than for its creative. That is a separate workflow and it belongs in the media plan, not in the claims review.

Surgeon and influencer posts. Two obligations stack. FTC's Endorsement Guides require disclosure of material connections, and the disclosure has to be clear on the post itself, not in a bio or a linked page. Payments and transfers of value to covered recipients are separately reportable under Open Payments. And a company that likes, shares, comments on, or repurposes a clinician's post about an unapproved use can be treated as having adopted that claim. Write the contract to say what the clinician may and may not claim, and monitor what actually posts.

Correcting third-party misinformation. FDA has described a framework for voluntarily addressing misinformation about an approved or cleared product that someone else created, and it is narrower than most teams assume: the response is expected to be limited, non-promotional, and tied to the specific misinformation rather than used as an opening to promote.

The status here matters more than the framework, because this is the citation most competing content gets wrong. FDA's current document is "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers," a revised draft issued July 2024, docket FDA-2014-D-0447, announced at 89 FR 56387 on July 9, 2024. FDA states in that announcement that the revised draft "revises and replaces" the June 2014 draft "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices," and also states plainly that it "is not final nor is it in effect at this time."

So the honest answer to "which one should we follow" is that neither is binding, the 2014 draft is the one FDA has superseded in its own docket, and the July 2024 revised draft is where FDA's current thinking is written down. A company that wants to respond to misinformation about its device should have its regulatory and legal leads read the July 2024 draft and write a standing procedure before the situation arises, because these decisions get made under time pressure by whoever is watching the account.

Website claim drift. The reviewed PDF and the page that actually went live diverge, in both directions. A product page updated for a new indication leaves the old claim in the meta description, the alt text, the FAQ schema, and a two-year-old blog post that still ranks. Every one of those is a claim. So is a datasheet PDF sitting in an uploads folder with no page linking to it, still indexed, still stating the superseded specification. Audit the artifacts, not just the page.

AI-generated copy. A claim drafted by a model is your claim. There is no regulatory carve-out for tooling, and "the AI wrote it" is not a substantiation. Two practical rules: never let a model generate the indication sentence, and treat AI-drafted copy as a first draft that enters the same claims matrix as everything else, with a source required per line.

AI answer engines paraphrasing you. Assistants summarize product pages and drop the qualifiers first. You cannot control the paraphrase, but you can control what there is to paraphrase. Keep the indication stated plainly and close to the claim it qualifies, so a summary that keeps one sentence keeps the right one.

Version control across every surface. The same claim lives on the site, in the deck, in the PDF, on the booth panel, in the ad, and in a distributor's translated version you have never seen. When a claim changes, it changes everywhere or the old version is a live exposure. Keep a claim register that lists every surface each claim appears on. This is tedious and it is the single highest-value artifact on the list.

For conference-specific rules covering booths, product theaters, sponsored education, and Sunshine Act tracking at shows, see the sibling guide: FDA conference compliance.

The Pre-Ship Checklist

Run this against a real piece. Each line is either satisfied or it is not, and a piece that has an unsatisfied line is not ready regardless of the ship date.

A. Before review starts

• The claims matrix exists, listing every claim on the piece with its proposed source document
• The current authorized indication text is attached, pulled from the clearance, approval, or granting document rather than an internal summary
• The market or markets this piece will be used in are stated
• The audience is stated: clinician, hospital purchaser, payor, patient, distributor
• The copy is being reviewed before design freeze

B. The status pass

• Regulatory status is stated correctly for the pathway: cleared, approved, granted, or exempt
• No use of "FDA approved" for a 510(k) device, and no "FDA registered," "FDA certified," or "FDA listed" as marketing credentials
• Any designation mentioned is not presented as a finding of safety or effectiveness
• Trademark and registration symbols are correct and used on first reference
• Third-party marks are used within the scope of a current certificate or agreement

C. The claim pass

• Every claim maps to a row in the substantiation table, and to a real source document
• No claim is broader than the authorized indication in population, anatomy, setting, or endpoint
• Every superlative has a dated, scoped verification memo and a review date
• Every comparative claim has head-to-head evidence on that comparison and that endpoint
• No absolute safety claim appears anywhere on the piece
• Data is presented with its population, sample size, and limitations intact
• Headlines, subheads, callouts, and captions have been reviewed as claims, because they are

D. The labeling pass

• A determination has been made and recorded: is this piece labeling, or is it advertising?
• If labeling, it has a document number and revision and has entered change control
• Required labeling elements for the piece type are present
• The piece does not contradict, narrow, or soften anything in the FDA-required labeling

E. The digital pass, for any piece that goes online

• Meta title, meta description, alt text, and structured data have been read as claims
• Superseded PDFs and datasheets with old claims have been removed or redirected, not just unlinked
• Market gating is in place if the claims differ between markets
• Any endorser content carries a clear material-connection disclosure on the content itself
• Any AI-drafted line entered the claims matrix with a source, like every other line

F. The sign-off pass

• Regulatory has reviewed and every comment is resolved or explicitly accepted
• Clinical has approved how the evidence is characterized, not just the conclusion
• Legal has cleared the comparative and superlative claims
• One named approver, who is not the author, has signed and dated
• The approved file, the claims matrix, and every source document are archived together
• The claim register is updated so this piece can be found when a claim changes

G. After it ships

• A review date is on the calendar, tied to the shortest-lived claim on the piece
• Field-created materials are audited against the approved library on a set cadence
• Distributor and translated versions have been checked against the approved source

When Regulatory Says No

A rejection is usually not a wall. It is information about which of four things is missing, and each one has a different move.

If the claim is broader than the indication, narrow it to the indication. This is the most common rejection and the easiest fix. The narrower claim is frequently the better claim anyway, because it is specific, and specific claims are more persuasive to clinicians than category claims.

If the claim is a superiority claim without head-to-head data, change the claim type. A superiority claim can often become an attribute claim that stands on its own evidence. Describe what your device does and what was measured, without ranking it against a competitor. You keep the substance and you drop the exposure.

If the data is real but the channel is wrong, change the channel. Information about an unapproved use has a path, and that path is not the brochure. FDA has addressed two different situations, and they are at different levels of maturity.

The proactive case, where a firm wants to share scientific information about an unapproved use with healthcare providers, is covered by "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers," docket FDA-2008-D-0053. This one was finalized in January 2025, which is the detail most published content still has wrong, since it circulated as an October 2023 draft for over a year. It is the operative document.

The reactive case, where someone asks a question the firm did not prompt, is covered by "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices," docket FDA-2011-D-0868, issued December 2011 and still a draft after more than a decade. It is FDA's stated thinking and nothing more.

Both sit with medical affairs under a written procedure, not with sales or marketing. What a marketer actually needs is the handoff, and it is short. Route the request or the idea to medical affairs without answering it. Do not forward the reprint, do not summarize the study in an email, and do not have the rep "just send something over." Log what was asked, by whom, and when. Keep the response out of the promotional channel entirely, which means it does not become a brochure page, a booth panel, a slide in the standard deck, or a blog post. The moment the same content is pushed to an audience that did not ask for it, it is promotion again, and the guidance that permitted the response no longer describes what happened.

If the evidence does not exist yet, decide whether to go get it. Sometimes the answer is a study. Sometimes it is a new 510(k) for the expanded indication. Both are real options with real timelines, and both are decisions for the leadership team rather than for the person laying out the brochure. The important part is that the decision gets made rather than deferred, because a deferred decision tends to reappear as a headline someone quietly widened.

What not to do. Do not shop the claim to a reviewer who will say yes. Do not move a rejected claim from the brochure into the trade show booth, the ad, or the rep deck, since the rules do not change by channel. Do not ship the piece with the claim removed from the PDF but still live in the web version. And do not treat a regulatory reviewer as an obstacle, because the reviewer who catches a claim in draft is doing the cheap version of the work that a warning letter does expensively and in public.

Frequently Asked Questions

What does a medical device promotional piece need before it ships? Three things should be documented before release: the cleared or approved indication the piece maps to, the substantiation behind every performance and clinical claim, and a dated sign-off from whoever owns regulatory review. If any claim on the piece cannot be traced to a source document, the piece is not ready.

Can you say a 510(k) device is FDA approved? No. A 510(k) device is cleared, based on a determination of substantial equivalence to a legally marketed predicate. Under 21 CFR 807.97, representing that clearance denotes FDA approval is misleading and constitutes misbranding. Only devices that went through premarket approval are FDA approved. De Novo devices received marketing authorization through a granting order and are described as granted or authorized, not approved.

Who reviews medical device marketing materials? At minimum, regulatory affairs reviews the piece against the cleared indications and labeling, and a clinical or medical reviewer checks how the evidence is characterized. Larger organizations add legal for comparative and intellectual property exposure, and quality to determine whether the piece meets the definition of labeling and therefore falls under document control. Small device companies often have no formal review function at all, which is the most common failure point.

What is the difference between labeling and advertising for a medical device? Labeling includes the label on the device and written, printed, or graphic material accompanying the device, and it can extend to promotional pieces that are textually related to the device and distributed with it. Advertising sits outside that definition, and section 502(r) of the FD&C Act says so directly by excluding printed matter that FDA determines to be labeling. The distinction matters because labeling is a controlled document inside the quality management system and cannot be changed by marketing alone, while a piece that is only advertising follows a lighter internal path. One exception drives most of the confusion: for a restricted device, FDA's authority reaches advertising too, through sections 502(q) and 502(r).

Can a medical device be promoted before FDA clearance? No. A device that has not received marketing authorization is not promoted for its intended use, and 21 CFR 812.7 prohibits promoting or test marketing an investigational device until FDA has approved it for commercial distribution, and prohibits representing that it is safe or effective for the purposes being investigated. Work that typically proceeds in that window includes building the site, the messaging, and the sales tools, and describing the company and the technology platform, while claims about clinical performance wait for the clearance, approval, or granting order. Exhibit-hall display of a device that is not yet authorized is a related but separate question and should be worked out with regulatory before show week.

---

What to do next

1. Build the claims matrix for one piece. Pick the piece you use most, list every claim in one column and its source in the other, and see how many rows come up empty. That number is your actual starting position.
2. Write down the review chain. Six steps, a named person on each, one approver who is not the author. One page. Most device companies do not have this written down anywhere, and writing it down is the majority of the fix.
3. Pull the current indication text from the authorization document, not from the internal one-pager, and make that file the single source every piece copies from.
4. Audit what is already live. Old PDFs, old blog posts, distributor versions, and rep decks all carry claims you approved under a different set of facts.
5. Need a second read on what your materials can say? Buzzbox Media works exclusively with medtech companies and healthcare associations, with over 15 years in the category, and reviews marketing claims against cleared labeling before the piece goes out. Book a 30-minute call.

Related reading: FDA marketing compliance for medical devices, FDA cleared vs FDA approved, clinical claims in medtech marketing, and the conference version of this workflow at FDA conference compliance. For claims strategy support, see regulatory marketing or start at Module 3 of the Medical Device Launch Roadmap.

This guide is general information, not legal or regulatory advice. Consult your regulatory affairs and legal teams before releasing any promotional material.

This guide is published by Buzzbox Media, a medical device marketing agency in Nashville. We run medical device marketing for medical device companies.

Continue reading

• FDA Conference Compliance: Booth Rules for Medical Devices, 8 min read
• Medical Device Launch Plan: Clearance to Month Twelve, 15 min read
• Marketing Orthopedic Devices to Surgeons and the Committees Behind Them, 15 min read