Medical devices classifications

Department of Health and Human Services, Food and Drug Administration. Medical devices classification/reclassification restricted devices analyte specific reagents. Final rule. Fed Register. 1997(Nov 21) 62243-45 [21CFR809, 21CFR864] http //www.fda.gov/cdrh/oivd/index.html (accessed August 19,2004). 

Class I refers to what level of medical device classification ... 

Fig. 3. Miscellaneous dyes used in cosmetics and medical devices. Dye classification (32), azo (33), anthraquinone (34), phthalocyanine (35), indigoid.

Color Additives. The FDA has created a unique classification and strict limitations on color additives (see also CoLORANTS FOR FOOD, DRUGS, COSMETICS, AND MEDICAL DEVICES). Certified color additives are synthetic organic dyes that ate described in an approved color additive petition. Each manufactured lot of a certified dye must be analyzed and certified by the EDA prior to usage. Color lakes are pigments (qv) that consist of an insoluble metallic salt of a certified color additive deposited on an inert substrate. Lakes are subject to the color additive regulations of the EDA and must be certified by EDA prior to use. Noncertifted color additives requite an approved color additive petition, but individual batches need not be EDA certified prior to use. 

Figure 9.5 Relationship between risk and classification of medical devices.

The previous chapter outlined how device classification and the use of standards provide the basis for effective regulation of medical devices, with particular focus on the application of design control standards to the development of devices. In this chapter we look at the process for evaluation and authorisation of devices, and see how the regulatory requirements vary depending on the perceived risk of the device as indicated by its classification. It will be noted that there is considerable variation between the approaches adopted in Europe and the US and that, compared to dmgs, practical harmonisation of requirements still remains to be adopted. 

Medical devices are regulated on the basis of a three-level risk classification. The highest risk products are the class 3 products that require premarket applications, almost always with clinical data that demonstrate that the product is safe and effective for the intended use. By default, a novel product is a class 3 product unless there is an approval application for initial approval as a class 2 device (the de novo process). Clinical trials for class 3 products before they are approved usually require an IDE, which is similar to the IND required for investigational drugs. 

A manufacturer must apply an appropriate conformity assessment procedure to their device in order to ensure that it complies with the essential requirements, after which they must certify this fact by completing a declaration of conformity. There is usually a choice of conformity assessment procedures open to a manufacturer, depending on a risk-based classification of the class into which the device falls. The two main approaches to conformity assessment are based either on an approved total quality management system audited to ISO 9000 series standard, as customised for medical devices with EN 46 000 series standard, or individual product assessment. 

Medical devices may be assisted in their function by pharmacological, immunological or metabolic means, but as soon as these means are not any more ancillary with respect to the principal purpose of a product, the product becomes a medicinal product. The claims made for a product, in accordance with its method of action may, in this context, represent an important factor for its classification as MD or medicinal product. Examples of MDs incorporating a medicinal substance with ancillary action include catheters coated with heparin or an antibiotic, bone cements containing antibiotic and blood bags containing anticoagulant. ... 

From a classification point of view, ocular endotamponades are classical medical devices. Their application inside the human eye requires, besides ultra-purity, special controls during the manufacturing as well as for the release of finished products. They must be non-toxic and sterile and have to meet the general requirements of the European Medical Device Directive (MDD). 

Revision of medical device regulations has occurred in other countries, including Canada and the United States, because of the European experience. In 1998, Canada changed its device regulations to include a risk-based classification system and 11 principles of safety and effectiveness, which were patterned after the essential requirements of the European MDD (22). 

In this case there is no sense of measuring a characteristic. With this data we use a system of classifications, with no natural ordering. For example, one of the factors that might influence the effectiveness of treatment could be the specific manufacturer of a medical device. Therefore, all patients would be classified as users of Smith , Jones or Williams equipment. There is no natural sequence to these they are just three different makes. 

Table la Classifications of medical devices marketed in the united states... 

Table lb Classifications of medical devices of the european union ... 

Two types of regulatory approvals exist for medical devices in the United States, 510(k) notification and premarket approval (PMA). The types of tests required for approval depend on the classification of the medical device. 510(k) notification involves marketing a device that is substantially equivalent to a device on the market prior to 1976. All devices introduced after 1976 that are not substantially equivalent to devices on the market before 1976 are automatically classified as Class 3 devices and require PMA (16). For a device fo be considered subsfantially equivalenf to a device on the market before 1976, it must have the same intended use, no new technological characteristics, and have the same performance as one or more devices on the market prior to 1976. In addition, all medical devices must be sterilized either by end-sterilization or by some other acceptable means that can be validated, which means that any test done in cell culture or in an animal model must be conducted on a device that has been validated to be sterile. Sterility validation is conducted on all medical devices as described in the literature (17). 

In vitro diagnostic (IVD) products These are medical devices which analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease. Classification for these devices can be found under 21 CER 862, 21 CER 86 , and 21 CER 866. 

Many Spanish hospital pharmacies participate in the selection, ordering, storage, distribution, and provision of information relating to medical devices. Such hospital pharmacies are also involved in rational use programs. A guide to medical devices used in Spanish hospitals has been published, which gives a classification to each device. 

Includes information for medical devices general, labeling, reporting, in vitro diagnostic products, investigational device exemptions, premarket approval, postmarket surveillance, and classification procedures. 

A variety of controlled vocabiilary codes can be used in some sources for more precise search results. Examples include the North American Industrial Classification System (NAICS), healthcare common procediire coding system (HCPCS), current procediiral terminology (CPT), Universal Medical Device Nomenclature System (UMDNS), and the International Classification of Disease (ICD). However, it is not always easy to determine which information soimce uses which code, if any, and which procedure or disease state the codes cover. 

International Classification of Standards (ICS) codes are used by most standards-issuing bodies. The classes relevant to medical devices are somewhat broad—for example, ICS field 11.040 is medical equipment and 11.140 is hospital equipment, while fields 25 and 29 cover various aspects of manufacturing engineering and electrical engineering, respectively. Nonetheless, use of these codes generally retrieves the most relevant search results. It is often effective to combine a broad code with a keyword search. The ICS codes are fisted in the standards databases as well as on the ISO Web site. 

Medical devices may contain medicinal substances which act on the body in a manner ancillary to the device. However, where such substances act in a manner that is more than ancillary, the product is regulated as a medicinal product rather than a medical device. In addition, in cases where there is doubt as to the classification of the product as a device or medicinal product, the provisions of 2004/27/EC state that the product shall be regulated as a medicinal product [13],... 

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