Medical Device Amendment

Congress expanded FDA s authority in 1962 with the Dmg Amendments of 1962, which stipulated that, before a dmg could be marketed, it must be shown to be effective as well as safe. In 1976, Congress similarly expanded FDA s authority over medical devices with the Medical Device Amendments. 

Other expansions of FDA s authority include the Dmg Price Competition and Patent Term Restoration Act of 1984, commonly known as the 1984 Amendments or the Waxman-Hatch Act, which was passed to attain quicker marketing of safe, effective, and less expensive generic dmgs and the Safe Medical Device Amendments of 1990, which was passed to correct perceived weaknesses in the implementation of the 1976 Device Amendments. Congress further expanded FDA authority over nutrition labeling and health and nutrient content claims on food labels with the Nutrition Labeling and Education Act of 1990. 

Sutures are regulated by the EDA as medical devices iatended for human use. The Eederal Eood, Dmg, and Cosmetic Act of 1938 has been amended many times, ia particular by the Medical Device Amendments of 1976. Devices have been under the jurisdiction of the EDA siace 1938. Section 513 of the Act requires the EDA to classify medical devices (sutures) ia one of three categories as follows. 

With the passage of the Medical Device Amendments of 1976 (PubHc Law 94-295) Congress created a new category of color additive by mandating the separate listing of colorants for use in medical devices if the color additive in them comes in dkect contact with the body for a significant period of time. 

Medical Device Amendments passed to ensure safety and effectiveness of medical devices, including diagnostic products. 

The regulation of medical devices in the U S was introduced with the Medical Device Amendments to FDC Act in 1976. These are supported by regulations published in 21 CFR parts 800-899. The Center for Devices and Radiological Health (CDRH) is the responsible section within the FDA for regulation of devices. 

Medical Device Amendment to the FDCA requiring for devices that not only effectiveness be proven, but also safety. 

Safe Medical Device Amendments, requiring more extensive testing of devices. 1992 Prescription Drug User Fee Act. Established the payment of fees for the filing of applications (e.g., IND, NDA, PLA, etc.)... 

Under the Medical Device Amendments of 1976, the FDA is responsible for premarket evaluation of all laboratory testing devices (in vitro diagnostics) intended to be commercially marketed in the United States. There are two major pathways for introducing a medical device into the marketplace the premarket notification [510(k) clearance] and the premarket approval (PMA). The purpose of the 510(k) is to establish that a device is substantially equivalent (SE) to a legally marketed (predicate) device. The purpose of the PMA evaluation process is to establish the intrinsic safety and effectiveness of a new device. Unless specifically exempt, a sponsor must have an approved PMA or cleared premarket notification [510(k)] by the FDA before a device may be legally marketed for IVD use (Fig. 1). 

The Medical Device Amendments pass to ensure safety and effectiveness of medical devices including diagnostic products, requiring some quality control, premarket approval, and performance standards on some products. 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

One court has interpreted the FD C Act as not authorising FDA to require restitution by a manufacturer to purchasers of a product that has been found to violate the FD C Act, but a more recent court decision has upheld restitution. The Medical Device Amendments of 1976 explicitly provide such authority for medical devices. ... 

Medical Device Amendments required manufacturers with the FDA and follow quality control procedures with some products needing premarket approval and others needing to meet performance standards before marketing. 

Test techniques for both tissue and blood responses of bio-materials have evolved significantly over the past several years. Increased government regulation of biomaterials in medical devices (as legislated in the U.S.A. in 1976 by the Medical Devices Amendments Act) has stimulated the development of a number of common vitro and vivo animal test systems for screening a wide variety of biomaterials and devices or implants for both tissue and blood responses. Tissue tests encompass a variety of in vitro and in vivo techniques. Blood tests include in vitro, ex vivo, and in vivo techniques. It is unlikely that successful medical devices or implants can be perfected for human use without such preliminary vitro and (especially) animal tests. 

Everything You Always Wanted to Know about the Medical Device Amendments and Weren t Afraid to Ask, U.S. Dept, of... 

On the national level, oversight is generally restricted to medical devices, and not on operational matters. Federal jurisdiction of medical devices falls under the purview of the Department of Health and Human Services, Public Health Service, Food and Drug Administration (FDA), Center for Devices and Radiological Health. Under federal law, medical devices are regulated under the Medical Device Amendments of 1976 and the Radiation Control for Health and Safety Act of 1968. Additional regulatory authorization is provided by the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, the FDA Reform and Enhancement Act of 1996, and the Food and Drug Administration Modernization Act of 1997. ... 

Transitional devices refer to devices that were regulated as drugs, prior to the enactment of the Medical Device Amendments Act of 1976. These devices were automatically placed into Class III, but may be transferred to Class I or II. 

New devices. As part of the General Controls requirements, the FDA must be notified prior to marketing any new (or modifying an existing) device for patient use. This premarket notification, called the 510(k) process after the relevant section in the Medical Device Amendments Act, allows the FDA to review the device for safety and efltcacy. 

There are two broad categories that a device can fall into. A device that was marketed prior to May 28, 1976 (the date that the Medical Device Amendments became effective) can continue to be sold. Also, a product that is substantially equivalent to a preamendment device can Ukewise be marketed. However, the FDA may require a premarket approval application for any Class III device (see below). Thus, these preamendment devices and their equivalents are approved by grandfathering. (Premarket notification to the FDA is still required to assure safety and efficacy.) Of course, the question of substantial equivalency is open to an infinite munber of interpretations. From the manufacturer s perspective, such a designation allows marketing the device without a much more laborious and expensive premarket approval process. 

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