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Durable medical equipment (DME) for home use is reusable equipment, such as walkers, hospital beds, wheelchairs, oxygen equipment and CPAP devices, that is used for a medical reason and is appropriate for use in the home. Two different public tests apply to it: Medicare’s definition of DME in 42 CFR 414.202, and the FDA’s view of devices used outside a professional healthcare facility. This page sets them side by side so you can tell what a given item is, who uses it and what to check before it is set up at home.
This page describes products and general use; it is not medical advice.
Looking for coverage rules, rentals or supplier screening? See Medicare Part B durable medical equipment and how to screen a DME vendor. For the FDA device classes, see types of medical equipment. This page covers the home-use lens only.
What counts as durable medical equipment
Medicare describes DME as equipment that is durable (can withstand repeated use), used for a medical reason, typically only useful to someone who is sick or injured, used in your home, and expected to last at least 3 years (Medicare.gov, checked 2026-11-01). Medicare’s examples include canes, commode chairs, crutches, walkers, hospital beds, wheelchairs and scooters, plus CPAP therapy, glucose monitors, infusion pumps and oxygen equipment. The list is not exhaustive.
Who uses it: people with an illness or injury who use the item at home, the clinicians who prescribe it, and the suppliers and home health agencies that furnish it.
The five conditions in the regulation
The regulatory definition is in 42 CFR 414.202 (eCFR, checked 2026-11-01). It defines DME as equipment furnished by a supplier or home health agency that meets all of the conditions below.
| Condition | Wording in 42 CFR 414.202 | Plain-language version on Medicare.gov |
|---|---|---|
| Repeated use | Can withstand repeated use | Durable (can withstand repeated use) |
| Lifespan | Has an expected life of at least 3 years (for items classified as DME after January 1, 2012) | Expected to last at least 3 years |
| Medical purpose | Is primarily and customarily used to serve a medical purpose | Used for a medical reason |
| Illness or injury | Generally is not useful to an individual in the absence of an illness or injury | Typically only useful to someone who is sick or injured |
| Home setting | Is appropriate for use in the home | Used in your home |
The 3-year condition applies to items classified as DME after January 1, 2012, so check the date qualifier before applying it to an older item class.
Home medical equipment and supplies: how the terms differ
“Durable medical equipment” is a Medicare term with the five conditions above. “Home use device” is an FDA term. The FDA describes home use devices as devices intended for users in any environment outside of a professional healthcare facility (FDA, checked 2026-11-01). The two tests ask different questions, so an item can pass one without the other.
| Term | Who defines it | Question it answers |
|---|---|---|
| Durable medical equipment | Medicare, 42 CFR 414.202 | Is this reusable, long-lived equipment with a medical purpose that suits the home? |
| Home use device | FDA, Center for Devices and Radiological Health | Is this device intended for use outside a professional healthcare facility? |
Why the FDA treats home use as a distinct setting
The FDA’s guidance on design considerations for devices intended for home use describes home use as involving interactions among the user (often a layperson), the use environment and the device, and says devices used in the home or other non-clinical settings are associated with unique risks (FDA, checked 2026-11-01). The agency’s home use devices page states that the regulatory authority alone is not enough to ensure that devices are safe and effective when used in the home. It adds that complex devices are increasingly used at home, many times under unsuitable conditions, and that safe operation matters most for devices with sophisticated requirements for proper operation or maintenance.
A home-readiness checklist: user, environment, device
The FDA’s three-part framing (user, use environment, device) gives a structure for reviewing any item before it goes home. These are questions to put to the prescriber, the supplier and the manufacturer’s instructions for use; they are not clinical advice.
- User. Who will operate it day to day: the patient, a family member or another layperson? Do the instructions for use assume training that person has not had?
- Environment. The FDA notes that complex devices are often used at home under unsuitable conditions. Does the home match the conditions the instructions for use describe?
- Device. Does the item have sophisticated operation or maintenance requirements? If so, who is responsible for them after delivery?
For a broader item-by-item list, see home caregiver supplies by category; for a worked item example, see standard walkers.
Safe use and handling basics
Use equipment as its manufacturer’s instructions for use describe, and keep those instructions with the item. The FDA’s home-use material identifies the layperson user, the home environment and the complexity of operation or maintenance as the main sources of risk, so those are the places to look first when something is unclear. Questions about an individual’s use of an item belong with the prescribing clinician.
Common mistakes
- Treating “medical supply” and “durable medical equipment” as one category. DME is defined by durability, medical purpose, suitability for the home and the other conditions in the table above.
- Assuming that a device cleared for use outside a facility is also covered as DME, or the reverse. The Medicare and FDA tests are separate.
- Applying the 3-year condition without its January 1, 2012 qualifier.
- Assuming that any supplier can furnish Medicare-covered DME. Medicare.gov says to make sure your doctors and DME suppliers are enrolled in Medicare and will accept assignment.
Questions to ask a supplier
- Is the supplier enrolled in Medicare, and will it accept assignment? (Medicare.gov, checked 2026-11-01)
- Which instructions for use come with the item, and who explains them to the person who will operate it?
- Who handles operation or maintenance problems after delivery?
More on vendor screening: durable medical equipment vendors.
FAQ
What is durable medical equipment for home use?
Reusable equipment used for a medical reason, useful mainly to someone who is sick or injured, appropriate for use in the home and expected to last at least 3 years under Medicare’s description. Examples Medicare lists include walkers, hospital beds, wheelchairs and oxygen equipment.
What is the difference between home medical equipment and durable medical equipment?
Durable medical equipment is the Medicare term with five defined conditions. “Home use device” is the FDA’s term for devices intended for use outside a professional healthcare facility. An item can meet one definition without the other.
Does the FDA regulate home medical equipment?
The FDA regulates medical devices, including those intended for home use, and publishes guidance for manufacturers on home-use design. Its home use devices page also says that regulatory authority alone is not enough to ensure safe and effective use in the home.
Sources
- Medicare.gov, Durable medical equipment (DME) coverage, checked 2026-11-01.
- eCFR, 42 CFR 414.202, Definitions, checked 2026-11-01.
- FDA, Home use devices, checked 2026-11-01.
- FDA, Design considerations for devices intended for home use, checked 2026-11-01.
