Medical devices and

Wear of medical devices and biomaterials can affect quality of life. Wear of tooth fillings, artificial joints and heart valves can be inconvenient, costly (more frequent replacement) or even life-threateiiiiig (premature breakdowns). Wear of components can also cause accidents. Worn brakes and tires can cause automobile accidents, worn electrical cords can result in electrocution and fires and worn out seals can lead to radiation leaks at nuclear power plants. 

Plastics continue to make inroads regarding medical applications. Certain plastics have been found to exist in the environment of living tissues. In addition to being of direct aid in medicine, they are also important in medical devices and packaging medical items. 

Parts 800 to 1299. Medical devices and radiological health. Regulations under the Federal Import Milk Act, the Federal Tea Importation Act, the Federal Caustic Poison Act, and for control of communicable diseases and interstate conveyance sanitation. 

The subcategories, active implantable medical devices and in vitro medicai devices are further defined as ... 

Guidance on demarcation between medical devices and medicines MEDDEV Guide 2.1/3 MEDDEV Guide 2.14/1... 

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. 

Kuhn, A. T. Jones, M. P. (1982). A model for the dissolution and fluoride release from dental cements. Biomaterials, Medical Devices and Artificial Organs, 10, 281-93. 

As mentioned previously (and discussed in detail in Sec. IX), contact lens products have specific guidelines that focus on compatibility with the contact lens and biocompatibility with the cornea and conjunctiva [75], These solutions are viewed as new medical devices and require testing with the contact lenses with which they are to be used. Tests include a 21-day ocular study in rabbits and employ the appropriate types of contact lenses with which they are to be used and may include the other solutions that might be used with the lens. Additional tests to evaluate cytotoxicity potential, acute toxicity, sensitization potential (allergenicity), and risks specific to the preparation are also required [75-77], These tests are sufficient to meet requirements in the majority of countries, though testing requirements for Japan are currently much more extensive. 

At the FDA, a major effort is under way to streamline the process by which medical devices are reviewed and evaluated. The FDA has made significant progress in its quest to provide review of medical devices in a more timely manner. In fact, the agency has completely cleared its backlog of 510(k) and PM A applications for medical devices and is now turning its attention to quicker, more efficient reviews... 

McDade R.L., Fulton R.J., True multiplexed analysis by computer-enhanced flow cytometry, Medical Device and Diagnostic Industry, 6 pp., April 1977. 

A small number of biotechnology products are classified as medical devices and, hence, are regulated by the Center for Devices and Radiological Health (CDRH). The first approved biotech product to come under the auspices of the CDRH was OP-1 implant. Marketed by Stryker Biotech, OP-1 implant is a sterile powder composed of recombinant human oestrogenic protein-1 (OP-1) along with bovine collagen. It is used to treat fractured bones that fail to heal. The product is mixed with sterile saline immediately before application, and entails surgical insertion of the paste into the fracture. 

Pisano, D. and Mantus, D. 2003. FDA Regulatory Affairs, a Guide for prescription Drugs, Medical Devices and Biologies. CRC Press. 

For submissions involving medical devices and/or drugs that are not clearly addressed in this agreement, sponsors are referred to the product jurisdiction regulations (21 CFR Part 3). These regulations have been promulgated to facilitate the determination of regulatory jurisdiction but do not exclude the possibility for a collaborative review between the centers. 

Medical devices and pharmaceuticals are two closely related communities. Their materials of concern are agents intended as therapeutics or as components of devices to be used in healthcare, where the production worker or healthcare provider (doctor, nurse, or pharmacist) may have a significant chance of exposure, but the major concern is for those patients who receive or use the drug or device. Various centers of the Food and Drug Administration (FDA) are the primary U.S. regulators. 

This directive accompanies directive 2002/96/EC, also known as WEEE, which addresses the handling of wastes from electrical and electronic wastes. These wastes cover a wide range of electrical and electronic products from household appliances such as refrigerators, freezers and microwaves to personal computers, cell phones to electrical toys, medical devices and electrical tools. As specified in Article 4 (1) of directive 2002/95/EC the following substances which are contained in all of the defined product groups have to be substituted from lJuly 2006on ... 

The example of the textile chain demonstrates (i) how much the techni-cal/aesthetic quality of products and chemicals-related product security are interdependent and (ii) what requirements exist for a quality management system beyond the supply chain level. Only the major brands can take this initiative on a global scale. For cosmetic, medical devices and food products, as well as technical products with high safety requirements (such as aircraft), management systems beyond supply chain level have now become a matter of survival. The same holds true for products that are subject to special waste and design regulations in Europe (such as automotive vehicles and electronic equipment). 

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