Medical device complexities

Polymers and Coatings Advances ia polymer chemistry have resulted ia many successful medical devices, including diagnostic assays (26). Polymers (qv), which can be manufactured ia a wide range of compositions, ate used to enhance speed, sensitivity, and versatiUty of both biosensors and dry chemistry systems to measure vital analytes. Their properties can be regulated by composition variations and modifications. Furthermore, polymers can be configured iato simple to complex shapes. 

AH implantable medical devices ate complex in design, materials, and implementation procedures. The biocompatibiUty, biodurabiUty, and efficacy of medical devices are the subject of extensive research by biomaterials scientists, device manufacturers, and health care professionals. 

US-FDA performs premarket review of laboratory, animal, and human clinical testing for new human dmgs and biologies, complex medical devices, food and color additives, and animal dmgs for safety and effectiveness. Infant formulas are reviewed for required nutrient content and safety in manufacturing practices. 

Large parts can require considerable power requirements. Resistance welding has been applied to complex joints in automotive applications, including vehicle bumpers and panels, and joints in plastic pipe, and in medical devices. Resistance wire welding is not restricted to flat surfaces. If access to the heating element is possible, repair of badly bonded joints is possible, and joints can be disassembled in a reverse process to which they were made. 

The definition s reference to software extends the scope of medical devices to include those based on programmable technology. Such devices can be extremely complex and consist of a large... 

The hazards posed to a medical device associated with its manufacture should also be included. Complex arrangements may require multiple phases of hazard analysis. 

The FDA considers LDTs medical devices subject to FDA regulatory oversight, but witli very few exceptions has not executed this authority the high complexity laboratories that develop LDTs are regulated by the Center for Medicare and Medicaid Services under the provisions of the Chnicai Laboratory Improvement Act [CLIA] of 1988). With the ASR category, the FDA shifted its focus from the laboratory to the manufacturers of reagents, and proposed controls and restrictions to ensure their quality and consistency, and to clarify that a laboratory setting up these tests is responsible for the tests performance. 

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