FDA Definition of a Device

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products1 with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA)2 as a medical device and is subject to premarketing and postmarketing regulatory controls. A device is:

  • "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

This definition provides a clear distinction between a medical device and other FDA regulated products such as drugs. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. Human drugs are regulated by FDA's Center for Drug Evaluation and Research3 (CDER). Biological products which include blood and blood products, and blood banking equipment are regulated by FDA's Center for Biologics Evaluation and Research4 (CBER).

Medicare and Devices

Medicare processes claims using existing criteria to determine medical necessity. Physicians are responsible for notifying the Medicare carrier of the device and to seek reimbursement. 

Devices that may be covered under Medicare include:

  • those approved by the FDA through the Pre-Market Approval (PMA) process
  • those cleared by FDA through 510(k) process
  • FDA-approved Category B devices - The local Medicare office determines if the device will be paid based on data submitted by the provider.
  • Hospital IRB approved IDE (investigational device exemption) devices (same criteria as Category B)

Criteria for coverage on FDA-approved IDE category B devices:

  • The device must be used in FDA approved trial
  • The device must be used in accordance with protocol
  • There may be an established national policy as contained in existing manual instructions, e.g., National Coverage Determinations Manual instructions, etc.;
  • In the absence of national policy, there may be a local policy for similar FDA-approved devices
  • There may be Policy/Position papers or recommendations made by pertinent national and/or local specialty societies.

Category A Devices

The CMS Manual System Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) has published a detailed report regarding coverage of routine costs of clinical trials involving Investigational Device Exemption (IDE) Category A Devices. Click here to view.

When billing for devices, they should be billed with modifier Q0 and the IDE number should be indicated in field 14 (NSF) or position 180 (ANSI). Modifier Q0 is an informational modifier and has no impact on reimbursement.

Source: Medicare Benefit Policy Manual chapter 14