Most medical devices can be classified by finding the matching description of the device amongst one of the 16 medical specialty “panels” listed in Title 2138 of the Code of Federal Regulations. For each of the devices classified by the FDA, the CFR gives a general descrip­tion including the intended use, the class to which […]

Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. They are devices that are defined as those used for “supporting or sustaining human life or for a use which is of substantial importance […]

Class II27 devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assur­ances. In addition to complying with general controls, Class II devices are also subject to special controls. Note, a few Class II devices are exempt from the premarket notification.28 Special […]

Class I medical devices have the least amount of regulatory control. Class I devices pres­ent minimal potential harm to the user. These devices are typically simple in design and manufacture, and have a history of safe use and are only subject to general controls designed to achieve safety and effectiveness through the control of manufacturing, […]

The FDA17 has established classifications for approximately 1700 different generic types of devices, and grouped them into 16 medical specialties, referred to as panels. Each of these generic types of devices is assigned to one of the three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the […]

22.3.1 Medical Device Definition A medical device is defined16 within the Food Drug & Cosmetic Act as “… 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 […]

The MDUFMA was enacted largely to improve the efficiency and predictability of the medical device review process. Among other provisions, MDUFMA authorizes the FDA to impose user fees for premarket reviews of certain medical device applications. In exchange, the FDA is expected to meet certain performance goals designed to expedite and improve medical device reviews. […]

In 1997, the FDAMA (see US Public Law 105-115, 21 USC 301) expanded the Pre­scription Drug User Fee Act (PDUFA)11 policies by codifying a number of practices that had become common at the FDA. The legislation included provisions regarding user access to experimental drugs and medical devices, information on clinical trials, pharmacy com­pounding, food safety […]

The Safe Medical Device Amendments of 1990 was signed into law on November 28, 1990. The objective intent for Congress amending the Food, Drug, and Cosmetic Act was to provide greater assurance regarding the safety and effectiveness of the 1700 types of medical devices that FDA regulates. The new legislation gave FDA additional authority to […]