Device classification

Respiratory protective devices - Classification superseded BS 6928 1988 Respiratory protective devices - List of equivalent terms. Supersedes BS 6930 1988 Respiratory protective devices - Full face masks - Requirements, testing, marking. Supersedes BS EN 136-10 1992 and BS 7355 1990... 

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. 

In these devices classification occurs in the space over a fluidized bed from which fine particles are carried away with the air stream. The air velocity must essentially exceed the maximal fluidization velocity of fine fraction. These classifiers operate on the gravitational counterflow separation principle with fluidized bed used to increase particles residence time in the separator. Coarse particles can move horizontally across the bed to the exit, which is another advantage of this device. 

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). 

Medical devices are regulated by the Food, Drug, and Cosmetic Act, the Center for Devices and Radiological Health, and the Office of Device Regulation. Device classification <[Pg.45]

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

The patient assistive devices classification includes items such as walkers, bedpans, prosthetic limbs, canes, robotics, trapeze bars, wheelchair, orthot-ics (i.e., braces and shoes), patient transfer devices, and stand assist lifts. The six items belonging to the nurse protective devices classification are gloves, face masks, patient transfer devices, hand sanitizer dispensers, mechanical lifts, and gowns. The pahent protective devices classification includes items such as listed below [4] ... 

TABLE 21-4 Laser Device Classification and Risk Assessment... 

There is a huge variety of medical devices. The range and depth of medical devices (and medical textiles) can be appreciated from Table 12.1, where the FDA classificafimi of medical devices into speciality Device Classification Panels such as Cardiovascular... 

FDA Device Classification Panels, 2014. FDA Device Classification Panels [OnUne]. Available http //www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/... 

In the FDA regulatory classifications there are three classes of medical devices Class I, Class II, and Class III. This classification is based upon classifications for medical devices currently legally marketed in the United States. The FDA determines the device classification by the device s intended use and the risk that it presents to the patient. New medical devices are compared to legally marketed medical devices with the same intended use and technological characteristics to determine the classification. 

Although different authorities have different systems of premarket review, they all apply a similar risk-management philosophy in which all medical devices must satisfy safety and performance, quality system, and labeling requirements. The degree of regulatory scrutiny increases with the potential risks of the medical device, as evidenced by the risk-based device classification system proposed by the GHTF. 

Premarketing controls are specific to devices and device classifications. Premarketing controls for a medical device may include clearance to market by a 510(k) or approval to market by a PMA. 

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