Prescription requirements for medical devices are set by the FDA under 21 CFR 801.109, which restricts any device that cannot be used safely without a licensed practitioner’s supervision. If a device carries the “Rx only” symbol or a caution statement limiting sale to a practitioner’s order, you need a written prescription from a physician, dentist, or other state-licensed practitioner before a supplier can dispense it.1eCFR. 21 CFR 801.109 – Prescription Devices The order has to contain specific information, the underlying medical visit has to meet timing rules if Medicare is paying, and certain categories of equipment need prior authorization on top of the prescription itself.
Which Devices Need a Prescription and Which Don’t
The FDA does not require a prescription for every medical device. The dividing line under 21 CFR 801.109 is whether the device can be used safely by a consumer following written instructions alone. When a device could cause harm without professional oversight, when its use demands training, or when safety measures make self-directed use impractical, federal law channels access through a licensed practitioner’s order.1eCFR. 21 CFR 801.109 – Prescription Devices
Devices that require a prescription include CPAP and other positive airway pressure machines, cardiac monitors, powered wheelchairs, insulin pumps, certain home-use respiratory equipment, custom orthotic braces, and prosthetic limbs. Hearing aids sit on both sides of the line. Since 2022, the FDA has allowed over-the-counter hearing aids for adults 18 and older with perceived mild to moderate hearing loss, sold directly in stores and online. Hearing aids for severe hearing loss or for anyone under 18 still require a prescription and professional fitting.2U.S. Food and Drug Administration. OTC Hearing Aids – What You Should Know
Blood pressure cuffs, pulse oximeters, basic thermometers, canes, walkers without specialized features, and standard bandaging supplies are generally available without any professional authorization. The simplest test is the packaging. If it carries the “Rx only” label, you need a prescription. If it doesn’t, you can buy it off the shelf. A device that reaches consumers without the correct labeling is considered misbranded under federal law.3Office of the Law Revision Counsel. 21 USC 352 – Misbranded Drugs and Devices
Who Can Write the Order
Federal law does not limit device prescriptions to physicians alone. The regulation allows a restricted device to be sold on the order of a “physician, dentist, veterinarian, or any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device.”1eCFR. 21 CFR 801.109 – Prescription Devices State law controls which non-physician practitioners, such as nurse practitioners, physician assistants, and optometrists, have independent authority to sign device orders.
In roughly half the states, nurse practitioners hold full independent practice and prescriptive authority and can sign a device order without physician involvement. In the remaining states, some level of physician collaboration or supervision is required. If you are working with a non-physician practitioner and are not sure about their authority, the practical check is whether the supplier accepts their order without requesting a co-signature.
For Medicare-covered equipment, the face-to-face encounter can be conducted by a physician, physician assistant, nurse practitioner, or clinical nurse specialist. When the encounter is performed by a non-physician practitioner, a physician must co-sign the relevant portion of the medical record.4Centers for Medicare & Medicaid Services. Detailed Written Orders and Face-to-Face Encounters
What the Written Order Must Contain
A device order that reaches a supplier with missing fields gets rejected. For Medicare-covered durable medical equipment, CMS requires a Standard Written Order containing:
- The beneficiary’s name or Medicare Beneficiary Identifier number
- A clear description of the item, specific enough for the supplier to identify the correct product and billing code
- The quantity ordered, when applicable
- The treating practitioner’s name or National Provider Identifier (NPI)
- The date the order was written
- The treating practitioner’s signature
The order is not valid without the practitioner’s signature, and the complete written order must reach the supplier before any claim for Medicare payment can be submitted.5Centers for Medicare & Medicaid Services. DMEPOS Order and Face-to-Face Encounter Requirements Most private insurers follow a similar format. If you are ordering through a medical supply company, ask for their order form template or check the manufacturer’s website for a standardized form.
Certain categories of equipment demand more than a basic written order. Power mobility devices need a detailed “7-element order” that adds the diagnoses the device is expected to address, the date of the face-to-face examination, and the expected length of need. Some power wheelchair categories also require a separate specialty evaluation by a physical or occupational therapist with training in rehabilitation wheelchair assessments.6Centers for Medicare & Medicaid Services. Documentation Checklist for Prior Authorization Request – Certain Power Mobility Devices
The Medical Evaluation Behind the Order
A practitioner cannot write a device order without first establishing a clinical relationship through a medical evaluation. The device order cannot precede the encounter. For respiratory equipment, that evaluation might involve reviewing sleep study results or measuring blood oxygen levels. For a powered wheelchair, it involves assessing mobility limitations and whether less complex equipment would meet your needs. The visit is also the practitioner’s opportunity to demonstrate proper device use and discuss risks. A CPAP machine at the wrong pressure setting or a compression device applied incorrectly can cause real harm, which is why the FDA restricts these products in the first place.
Telehealth Visits
Telehealth can satisfy the encounter requirement in many situations. For Medicare-covered equipment, a telehealth encounter qualifies as a face-to-face visit as long as it meets CMS’s broader telehealth service and payment requirements.5Centers for Medicare & Medicaid Services. DMEPOS Order and Face-to-Face Encounter Requirements For non-Medicare patients, telehealth eligibility depends on state licensing rules and insurer policies. The telehealth visit must produce the same quality of clinical documentation as an in-person exam.
The Medicare Six-Month Timing Rule
For items of durable medical equipment that require a face-to-face encounter, Medicare requires that visit to occur within six months before the written order date.4Centers for Medicare & Medicaid Services. Detailed Written Orders and Face-to-Face Encounters The written order cannot be dated before the encounter. If your practitioner visit happened seven months ago, the order is invalid for Medicare purposes and you will need a new appointment. This catches people off guard when there is a gap between the doctor visit and actually placing the equipment order.
Extra Layers From Medicare and Private Insurance
The FDA’s prescription requirement gets you the order. Medicare and private insurance add verification steps before they will pay.
Standard Written Orders Replaced Certificates of Medical Necessity
CMS eliminated the Certificate of Medical Necessity and DME Information Form requirements effective January 1, 2023. All DMEPOS claims now require only a Standard Written Order from the treating practitioner as a condition for payment.7Centers for Medicare & Medicaid Services. Standard Documentation Requirements for All Claims Submitted to DME MACs The documentation standards for the underlying medical record remain unchanged.
Prior Authorization Categories
Some categories of durable medical equipment require prior authorization from Medicare before the supplier can fill the order. CMS maintains a Required Prior Authorization List, updated in January 2026, that covers:8Centers for Medicare & Medicaid Services. Required Prior Authorization List
- Power mobility devices, including power-operated vehicles and power wheelchairs across multiple configurations
- Lower limb prosthetics with microprocessor-controlled knee and ankle-foot systems
- Lumbar-sacral, knee, and ankle-foot orthoses
- Segmental home-use pneumatic compression devices, with or without calibrated gradient pressure
- Powered air flotation beds, pressure-reducing mattresses, and overlays
Prior authorization means the supplier submits the prescription, clinical documentation, and supporting medical records to Medicare for review before shipping. For power mobility devices, the package includes the face-to-face examination note, the 7-element order, a detailed product description, and, for certain wheelchair categories, a specialty evaluation by a licensed therapist.6Centers for Medicare & Medicaid Services. Documentation Checklist for Prior Authorization Request – Certain Power Mobility Devices Expect this to add days or weeks to your timeline.
Filling the Order
Once the signed order is complete, you or the practitioner’s office submits it to a durable medical equipment supplier or authorized vendor. Most suppliers accept electronic uploads through secure portals, faxes, or digital prescriptions transmitted through electronic prescribing systems. The supplier verifies the practitioner’s credentials, confirms the order meets documentation requirements, and checks your insurance coverage.
Insurance verification is where things slow down most often. For straightforward orders with no prior authorization requirement, verification and processing typically take a few business days. Standard equipment generally ships within three to ten business days after approval. Custom-built devices such as a molded orthotic or a configured power wheelchair take longer because they require assembly, fitting adjustments, or calibration.
Refills on Consumable Supplies
Many prescribed devices come with consumable components that need regular replacement, including CPAP masks, tubing, filters, and catheter supplies. A practitioner can write an initial order that covers both the device and future refills based on expected ongoing medical need. Even with a standing order, the supplier cannot auto-ship replacements on a fixed schedule.
Medicare’s refill rules require the supplier to contact you or your representative and confirm you actually need the refill before shipping. This contact must happen within 30 calendar days of the expected end of your current supply, and the refill itself cannot be delivered more than 10 calendar days before your current supply runs out.9Centers for Medicare & Medicaid Services. DMEPOS Refill Requirements The supplier must document who they contacted, the date, what was requested, and your affirmative response. Phone calls, texts, and emails all qualify. If a supplier ships you equipment you did not request and bills Medicare for it, that is worth reporting.
Buying From Foreign Sellers
Purchasing a prescription medical device from an international online seller is generally illegal. The FDA applies the same importation rules to medical devices as to drugs. Products purchased from foreign sources typically have not been approved by the FDA, and importing them for personal use violates federal law in most circumstances. A narrow exception exists for serious conditions where no effective treatment is available domestically, but the consumer must affirm in writing that the product is for personal use, the quantity generally cannot exceed a three-month supply, and the consumer must name a U.S.-licensed doctor responsible for their treatment.10U.S. Food and Drug Administration. Personal Importation The safest approach is to obtain prescription devices only through domestic suppliers.