Warranties on health devices and products: the FTC rules

Home blood pressure monitors, braces, mobility aids, hearing devices, electric toothbrushes and at-home skin devices are often sold with a warranty card in the box or a warranty badge on the product page. Practices that sell retail products, and the companies that make or distribute them, tend to treat that warranty as boilerplate copied from a competitor. Federal law does not make anyone offer a warranty. Once a company puts one in writing on a consumer product, though, the Magnuson-Moss Warranty Act and three FTC rules decide what it must say, how it must be labeled, where buyers must be able to read it, and what the company may not put in it.

This guide covers written warranties on products. Refund promises and satisfaction guarantees are covered in our guide to money-back guarantees in healthcare ads, hearing devices in OTC hearing aid advertising rules, and app store terms in app store and Google Play rules for health apps. What to pull and say when a product you sell is recalled is covered in marketing during a product recall.

The short version

• The Act covers written warranties on consumer products: tangible personal property normally used for personal, family or household purposes, 16 CFR 700.1(a). Warranties on services, such as a treatment or a repair technician’s labor, are not covered, 700.1(h).
• A written warranty on a product costing the consumer more than 10 dollars must be titled either “Full (statement of duration) Warranty” or “Limited Warranty”, 15 USC 2303 and 16 CFR 700.6.
• For products costing more than 15 dollars, the warranty must disclose nine items in one document in plain language, 16 CFR 701.3, and buyers must be able to read it before they buy, including online, 16 CFR 702.3.
• A company that gives a written warranty, or sells a service contract within 90 days of the sale, may not disclaim implied warranties, 15 USC 2308. A limited warranty may only limit their duration.
• A warranty may not be voided because the buyer used parts or service from someone else, unless those are provided free under the warranty or the FTC grants a waiver, 15 USC 2302(c) and 16 CFR 700.10.
• Buyers can sue for breach and may recover attorneys’ fees, 15 USC 2310(d), and a failure to follow the Act is treated as a violation of section 5 of the FTC Act, 2310(b).

Which health products are covered

The Act reaches products that people normally use at home, even if some buyers use them at work. Section 700.1(a) says a product is a consumer product if that use is not uncommon, that the share of sales to individuals does not decide it, and that any ambiguity will be resolved in favor of coverage. Home health devices, supports and braces, mobility aids, personal care devices and many retail items sold in a clinic fit easily.

Two limits matter to health businesses. First, services are out: section 700.1(h) says warranties on services are not covered, so a written promise about a procedure, a session package or the practice’s own workmanship is not a Magnuson-Moss warranty. Such promises remain subject to section 5 of the FTC Act and state law, and our guide to outcome claims covers results promises. A written agreement covering both replacement parts and the labor to install them is covered. Second, the disclosure and pre-sale rules in parts 701 and 702 exclude products purchased solely for commercial or industrial use, 701.1(b) and 702.1(b). Equipment a company sells only to clinics for clinical use, such as a treatment chair, is usually outside those two rules, though state warranty law still applies.

Not every statement about a product is a written warranty. Under 15 USC 2301(6) as restated in 701.1(c), a written warranty is a written promise that the material or workmanship is defect free or will meet a specified level of performance over a specified period of time, or a written undertaking to refund, repair, replace or take other remedial action if the product fails to meet its specifications. Section 700.3(a) says a product information disclosure without a specified time period is not a written warranty. A thirty-day return window for any reason is a term of sale, not a warranty, and 700.3(b) says sellers should not call it one; it suggests names such as “free trial period” and says such terms should be stated separately from any written warranty.

Full or limited: the label decides the duties

Section 2303 requires every written warranty on a consumer product costing more than 10 dollars to be designated either a “full (statement of duration) warranty” or a “limited warranty”. Section 700.6(a) says the designation should appear clearly and conspicuously as a caption or prominent title, separated from the text, and that these are the only designations allowed unless an FTC rule creates an exception. “Lifetime warranty” alone is not a designation.

A full warranty must meet the federal minimum standards in 15 USC 2304. The warrantor must fix the product within a reasonable time and without charge; may not limit the duration of implied warranties; may exclude consequential damages only if that exclusion conspicuously appears on the face of the warranty; and must let the consumer choose a refund or a free replacement if the product still has a defect after a reasonable number of repair attempts. The duties run to anyone who owns the product during the warranty period, 2304(b)(4), and the warrantor may not impose any duty other than notice of the defect unless it can show the duty is reasonable, 2304(b)(1).

That last point has practical effects. Section 700.7 says a requirement that the buyer return a registration card as a condition of a full warranty is an unreasonable duty, so “This warranty is void unless the registration card is returned” may not appear in a full warranty. A card may be offered as one way to record the purchase date if the warranty says that not returning it will not affect warranty rights. Section 700.9 adds that if a product only works when installed, a full warranty must include installation of the remedy without charge.

Any warranty that does not meet all of those standards is a limited warranty. A limited warranty can, for example, cover parts but not labor, require the buyer to pay shipping, or cover only the first buyer. It must still say so clearly under part 701.

What the warranty document must say

For a product costing the consumer more than 15 dollars, 16 CFR 701.3(a) requires the warrantor to disclose, clearly and conspicuously, in a single document in simple and readily understood language:

1. Who is covered, if the warranty is limited to the original buyer or otherwise does not cover every owner during its term.
2. What is covered, the products, parts, characteristics or components, and where needed, what is excluded.
3. What the warrantor will do in the event of a defect, malfunction or failure to conform, including what it will and will not pay for.
4. When coverage starts and how long it lasts, if it starts at a point other than the purchase date.
5. How to get warranty service, step by step, with the warrantor’s name and a mailing address, a responsible department or a toll-free number.
6. Any informal dispute settlement mechanism the warrantor has chosen under part 703.
7. Any limit on the duration of implied warranties, with the sentence the rule prescribes about state law.
8. Any exclusion or limit on incidental or consequential damages, again with the prescribed sentence.
9. The state rights sentence: “This warranty gives you specific legal rights, and you may also have other rights which vary from State to State.”

Items 7 and 8 must appear on the face of the warranty, and section 701.1(j)(3) says that for a warranty on a website, the face means in close proximity to where the warranty text begins. If returning a registration card really is a condition of coverage under a limited warranty, section 701.4 says the warranty must disclose it, and if a card looks like a condition but is not, the warranty must say that too.

Showing the warranty before the sale, including online

Part 702 makes warranty terms available before purchase for products costing more than 15 dollars. A seller with a store or front desk must display the warranty text near the product, or furnish it on request and post signs telling buyers it is available, 702.3(a). The warrantor must give sellers the materials to do that, such as a copy with each product or the text on the display package, 702.3(b)(1).

Since 2016 the warrantor may instead post the terms on its own website, 702.3(b)(2). If it does, it must state clearly on the product, packaging or manual the web address where the terms are posted and a phone number, postal address or other non-internet way to request a copy; send a free paper copy promptly on request; keep the terms posted clearly and accessibly; and give enough information for a buyer to identify which terms apply to which product.

Sellers who take orders without a visit, through a catalog or other mail order solicitation, must disclose either the full warranty text or the warrantor’s web address plus the fact that the warranty is free on request and where to ask, close to the product description, 702.3(c). For an online shop selling warranted products, the simplest approach is a link to the full warranty on each product page next to the price.

Implied warranties, disclaimers and “as is”

Implied warranties, such as the warranty that a product is fit for its ordinary purpose, come from state law. Section 2308(a) says a supplier may not disclaim or modify them if it makes any written warranty on the product, or if it enters into a service contract with the buyer at the time of sale or within 90 days after. Under 2308(b), a limited warranty may limit implied warranties to the duration of the written warranty, if the limit is conscionable, in clear and unmistakable language and prominently displayed on the face of the warranty. A full warranty may not limit them at all, 2304(a)(2). A disclaimer that breaks these rules is ineffective under federal and state law, 2308(c). So a product page that offers a one-year warranty and also says “sold as is, no other warranties” contradicts itself.

What a warranty may not say

• No tie-in to your brand of parts or service. Section 2302(c) bars conditioning a warranty on the use of an article or service identified by brand, trade or corporate name unless it is provided free under the warranty. Section 700.10(c) gives “This warranty is void if service is performed by anyone other than an authorized dealer and all replacement parts must be genuine parts” as a prohibited example. The warrantor may still exclude damage actually caused by unauthorized parts or service, and deny coverage when it can show that cause. For a device sold with consumables, such as replacement heads or filters, “use only our refills or the warranty is void” is the kind of clause this rule targets; the waiver in 2302(c) requires the warrantor to show the product works properly only with the named item and an FTC finding that a waiver is in the public interest.
• No “our decision is final”. Section 700.8 bars any statement that the warrantor’s or a third party’s decision is final or binding in a warranty dispute, or that the warrantor alone decides what counts as a defect.
• No full warranty that cuts off later owners. A full warranty may not restrict a transferee’s rights during its term, 700.6(b), though it may define its duration as the period the first buyer owns the product.

Retailers, distributors and practices that resell

A clinic or distributor that sells a product carrying the manufacturer’s warranty is not usually the warrantor. Section 700.4 says a supplier who does no more than distribute or sell a product covered by a written warranty that identifies another business as the warrantor is not liable for that warranty’s failure to comply with the Act. It adds that the seller’s own actions and written or oral statements can obligate it, and that a seller deemed under state law to have adopted the warranty is also obligated. Staff at a front desk who tell patients “we’ll replace it if it ever breaks” may be creating a promise the practice has to keep.

Resellers still have the pre-sale duty in 702.3(a) or (c): show the manufacturer’s warranty in the office or link it on the product page. A practice that sells under its own label, or a company that has products made for it, is usually the warrantor and carries the full set of duties.

Advertising a warranty

The FTC’s Guides for the Advertising of Warranties and Guarantees, 16 CFR part 239, apply to ads. Under 239.2, an ad that mentions a written warranty on a consumer product should tell buyers they can see the full warranty before sale where the product is sold, or for mail and phone orders, how to get the details free. Section 239.4 says an ad that uses “lifetime” or “life” should disclose, with clarity and prominence, whose or what life the term refers to: the buyer’s, the product’s or the period the first buyer owns it. Section 239.5 says to advertise a warranty only if you promptly and fully perform it. Section 239.3 covers satisfaction guarantees, discussed in our money-back guarantees guide.

Dispute programs and lawsuits

A warrantor may require buyers to try an informal dispute settlement mechanism before suing, but only if the mechanism meets the FTC’s rules in part 703 and the warranty says so, 15 USC 2310(a)(3). Part 703 sets requirements for how the mechanism is organized, who serves on it, how it operates, what records it keeps and yearly audits.

Under 2310(d), a consumer damaged by a failure to comply with the Act, a written or implied warranty or a service contract may sue in state court, or in federal court if the amount in controversy is at least 50,000 dollars counting all claims in the suit, and a consumer who finally prevails may be awarded costs and attorneys’ fees based on actual time spent. Under 2310(e), the warrantor must first get a reasonable opportunity to cure in most individual actions. The FTC and the Attorney General can also seek injunctions against deceptive warranties under 2310(c).

An illustration

This example is invented. [Company name] sells a home red light therapy panel through dermatology and med spa offices and its own online shop. The insert in the box says “Lifetime Warranty. Void if not registered within 30 days. Use only genuine [Company name] replacement bulbs. All decisions by [Company name] are final.” The product pages say “sold as is” in the footer, and front desk staff tell patients the company “replaces anything, no questions asked.”

The company’s attorney rewrites it. The title becomes “Limited Warranty: 2 years”. The new text covers defects in materials and workmanship for the first buyer, lists what is excluded, explains how to get service with a mailing address and phone number, and adds the three sentences part 701 requires. The registration condition, the bulb tie-in and the final decision line come out; the warranty instead excludes damage caused by third party bulbs, which the company would have to show. The “as is” footer is removed. Each product page links the warranty next to the price, the box lists the web address and phone number for a free copy, and the partner offices get a one-page script that says the warranty is the manufacturer’s and points patients to the link.

Checklist

• List every place a warranty appears: inserts, packaging, product pages, partner materials, ads and staff scripts.
• Decide whether the product is a consumer product, and whether you are the warrantor or a reseller.
• Title each warranty “Full (duration) Warranty” or “Limited Warranty” and check a full warranty meets every 2304 standard.
• Put the nine 701.3 disclosures in one plain-language document, with the implied warranty and damages limits on its face.
• Make the text available before purchase: in the office, on each product page, or on your website with the packaging statements 702.3(b)(2) requires.
• Remove brand tie-ins, final decision clauses, registration conditions in a full warranty, and “as is” disclaimers that conflict with a written warranty.
• If an ad says “lifetime”, say whose or what lifetime.
• Train staff not to promise more than the written warranty.
• Have an attorney check state warranty law before you print.

How we help

We build websites, local and organic search, Google Ads and lead generation and an AI front desk for independent practices and the companies that serve them. For warranties, that means product pages that link the full terms next to the price and front desk scripts that repeat the written terms instead of improvising. We are not a healthcare provider and we do not give legal or medical advice. Our guide to healthcare marketing rules covers the wider picture.

Sources

• 15 USC 2301 to 2312: Magnuson-Moss Warranty Act (Cornell LII, read November 1, 2026)
• 16 CFR part 700: Interpretations of Magnuson-Moss Warranty Act (eCFR, up to date as of October 29, 2026)
• 16 CFR part 701: Disclosure of written consumer product warranty terms and conditions
• 16 CFR part 702: Pre-sale availability of written warranty terms
• 16 CFR part 703: Informal dispute settlement procedures
• 16 CFR part 239: Guides for the Advertising of Warranties and Guarantees

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