MD Regulation (including IVD products) in the USA.

In the United States, the Food and Drug Administration (FDA) regulates medical devices (including in vitro diagnostic devices). In this article, we will consider how MD is determined in the USA (including the ones for in vitro diagnostics) and how MD can enter the US market.

Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, 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:

(A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

(B) 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

(C) 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 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 its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).

In order to enter the US market with the MD (including MD for in vitro diagnostics), it is first necessary to determine the class of MD using the FDA classification database. The MD class determines the complexity of the MD registration procedure.

Thus, first-class MD must be registered under the 510K procedure. According to this procedure, the applicant studies the existing market, finds analogues of their MD already registered in the USA, conducts a comparative analysis and sends this information to the FDA. This procedure applies, for example, to toothbrushes and is the simplest. In this case, the product is also exempted from passing the “general control” methods applicable to first class MD.

For products of the second class, in addition to general control methods, special ones are also applied. This group of methods is specific to each product and includes:

  • Performance standards
  • Postmarket surveillance
  • Patient registries
  • Special labeling requirements
  • Premarket data requirements
  • Guidelines

MD of the third class must pass the so-called premarket approval procedure, which takes about 180 days. Based on the results, in case of a positive decision, the applicant receives approval and, in some cases, a list of obligations and restrictions that must be met in order to bring the medical device to the market. Obligations and restrictions may include:

  • Restriction of the sale, distribution, or use of the device.
  • Continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended use.
  • Maintenance of records that will enable the applicant to submit to FDA information needed to trace patients if such information is necessary to protect the public health, etc.