Regulation of Medical Devices

In the field of Medicine and health sciences there are thousands upon thousands of devices that are utilized on a day to day basis. There has been a heightened rate of innovation over the past several decades. As a result of the necessity to place this universe of devices in categories, there was introduced a taxonomy methodology which accommodates all the devices within broad categories namely Class I, Class II, Class III up to Class VIII. However during conformity procedures, the medical devices are divided into four categories; Class I, Class IIa, Class IIb and Class III (Cornelia Henschke et al., 2015). This is the classification criteria according to the EU directives. It is based on the risks that are attached to each of the devices.

The Global Medical Device Nomenclature (GMDN) is an international coding system that was started having regard to the different existing nomenclatures (Cornelia Henschke et al., 2015). Class I devices are also known as the low risk devices. They undergo the least regulatory procedures, since their utilization does not expose the consumers to much jeopardy, physical or otherwise. Class I devices include dental floss, conventional wheelchair and spatula. Class II devices are of a higher risk than the latter and as such they require a more stringent regulatory procedure as an assurance that the consumers will not be exposed to the risks therein. They are divided into two; a and b. Class IIa are non-active and they include clinical thermometers, contact lenses and dental crown while Class IIb are active and they include x-ray machines, insulin pens, long-term corrective contact lenses and dental implant (Cornelia Henschke et al., 2015). Class III devices are the high-risk devices. Examples include cardiac stent and breast implant. Class IV devices are the active implantable devices. It lies under directive 90/385/EEC thus the risks associated are a bit higher than the latter while V to VIII are devices that require the assessment of the risk alongside the benefit accrued by the patient e.g. Ebola virus antigen IVD (Cornelia Henschke et al., 2015).

Class I devices require general controls. Class II devices require both general and special controls. In most instances Class I and II devices undergo premarket notification. Class III devices play a critical role in supporting or sustaining human life thus they must as a requirement undergo both need general and pre-market Approval (PMA). This is a scientific process of evaluation so as to ensure the devices are safe and effective (FDA, 2011). Class II and III devices may also undergo investigational device exemption (IDE).

Premarket Notification is done on devices that do not require a Premarket Approval. According to the U.S Food and Drug Administration, such devices go through a 510(k) procedure to show that they are on the minimum as safe and effective and an equivalent of a legally marketed device (21 CFR 807.92(a)(3) thus does not need to undergo a PMA. The submitters must as such compare their devices to one or more previous legally marketed devices as a way of backing their present equivalency claims. Premarket Approval on the other hand is the scientific process of evaluating the safety and effectiveness of Class III devices. These are devices that not only support and sustain human life but also pose a potential risk of illness or injury (FDA, 2011). They therefore go through a PMA application under Section 515 FD&C Act. The approval is based on scientific proof that the device is safe and effective for its intended utilization. The PMA applicant who would potentially become the PMA owner is a person who exercises ownership rights over the said patent and after approval he acquires  private license to distribute the product which he can extent to another (FDA, 2011). According to the FDA regulations, the FDA advisory committee may review the PMA at a public meeting and provide recommendations on whether FDA should approve the submission, thereafter the FDA will notify the applicant whether his product has been approved or denied. An investigational device exemption (IDE) is usually done to support the findings of a PMA and a small number of 510ks. It involves a clinical study on the said device so as to gather data on its safety and effectiveness.

Unlike the 510k and PMA, an IDE is not a mandatory procedure but is useful for learning and cultivation/ improvement of ideas on innovation. It may be used after a 510k and PMA has been conducted as a way of backing/ explaining the findings therein. A PMA procedure is more stringent than a 510k procedure because of the level or risks attached to the devices that are being investigated on.

Indeed it is accurate to infer that regulation of medical devices is ten years behind regulation of drugs. The first legislation that was introduced in the U.S to cater for the regulation of medical devices was the enactment of the 1938 Food Drug & Cosmetics Act while with regard to regulation of drugs as far back as 1848 there was already legislation thereto. This is highly attributed to the wake of advancement in technology during the 21st century. As far back as during the pre-historic era man had already started identifying plants and roots that would heal him during times of physical turmoil. With the emergence of modern society and governance, the medical fraternity also started regulating the drugs that would be submitted by manufacturers so as to be sure of their safety and effectiveness. However, the pace in technological advancement was slower thus causing the regulation of medical devices to be behind schedule.


Cornelia, H., et al., (2015). Taxonomy of Medical Devices in the Logic of Health Technology Assessment. International Journal of Technology Assessment in Health Care, 324–330. Cambridge University Press 2015.

U.S Food and Drug Administration, FDA. Overview of Regulatory Requirements: Medical Devices. Medical Devices. Retrieved from;

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U.S Food and Drug Administration, FDA. Device Advice: Investigational Device Exemption, IDE. Medical Devices. Retrieved from;

<> at 19 November 2016.