- 21 CFR
- Title 21 of the Code of Federal Regulations — the US food-and-drug rulebook; a number after it is one regulation, often the one that classifies a device type
- 510(k)
- premarket notification — the FDA route for a device shown to be as safe and effective as one already on the market; months, no clinical trial as a rule
- A####
- a HCPCS code for a supply — one billing code for a supply or an accessory; the letter A and four digits
- Class II
- FDA device class II — moderate-risk devices, usually cleared by 510(k)
- Class III
- FDA device class III — the highest-risk devices, usually approved by PMA
- CMS
- Centers for Medicare & Medicaid Services — the US agency that runs Medicare, and so decides what Medicare pays for
- CPT
- Current Procedural Terminology — the US billing codes for what a clinician does; owned by the American Medical Association
- De Novo
- De Novo classification request — the FDA route for a new, lower-risk device with no comparable product to point at; longer than a 510(k), usually needs clinical data
- DME
- durable medical equipment — equipment a patient uses at home, such as a pump or a stimulator, that Medicare pays for under its own rules
- DME MAC
- durable medical equipment Medicare administrative contractor — one of the four regional contractors that process Medicare's home-equipment claims and write its local coverage rules
- DMEPOS
- durable medical equipment, prosthetics, orthotics and supplies — the Medicare benefit and fee schedule that home equipment is paid under
- E####
- a HCPCS code for durable medical equipment — one billing code for a piece of home equipment; the letter E and four digits
- FDA
- US Food and Drug Administration — the US regulator that clears or approves a device before it can be sold
- FFS
- fee-for-service — the traditional form of Medicare that pays per item or service
- FTO
- freedom to operate — whether a product can be sold without infringing someone else's live patent
- HCPCS
- Healthcare Common Procedure Coding System — the US billing codes for equipment, supplies and some services; a code is how a payer recognises what to pay for
- IFU
- instructions for use — the labelling that says what a device is for and how to use it
- K######
- an FDA 510(k) clearance number — the public record of one cleared device; the letter K and six digits
- L#####
- a Medicare local coverage determination number — the public id of one local coverage rule; the letter L and five digits
- LCD
- local coverage determination — a Medicare contractor's rule, valid in its region, saying when something is covered
- MAC
- Medicare administrative contractor — a regional contractor that processes Medicare claims and writes local coverage rules
- MAUDE
- Manufacturer and User Facility Device Experience — the FDA's public database of reported device problems
- Medicare Advantage
- Medicare Advantage — Medicare delivered through a private insurer; must cover at least what Medicare covers
- mmHg
- millimetres of mercury — the unit blood pressure, and the suction of a wound pump, are measured in
- NCD
- national coverage determination — a Medicare rule, valid everywhere in the US, saying whether and when something is covered
- NCD ###.#
- a Medicare national coverage determination number — the public id of one national coverage rule
- NCT########
- a ClinicalTrials.gov registration number — the public id of one registered clinical trial
- NIV
- non-invasive ventilation — breathing support through a mask rather than a tube
- OSA
- obstructive sleep apnoea — breathing that repeatedly stops during sleep because the airway closes
- PFS
- physician fee schedule — the Medicare price list for what clinicians do
- PMID
- PubMed identifier — the public id of one published medical paper
- RVU
- relative value unit — the unit Medicare uses to price a clinician's work
- TAM
- total addressable market — how much money the whole market would be worth if every possible buyer bought
- tcCO2
- transcutaneous carbon dioxide — carbon dioxide measured through the skin, as a stand-in for a blood test