Medical device applications

But DSHEA is very different then the standard approval process for drugs and medical devices, and emphasizes the regulatory enforcement of label claims and advertising and marketing issues rather than the efficacy and quality of the supplements themselves. Unlike new drug and medical device applications, controlled clinical trials aren t part of the supplement review process, nor is any FDA inspection of a company s manufacturing facilities or quality control systems. 

Failure to include the required certifications in submissions can result in an application being refused for filing. In addition, NDAs and BLAs require the submission of auser fee form 3397 indicating that the fee has been submitted in the amount as required. Table 1 provides a matrix of the certifications required for drug, biologic, and medical device applications. 

The RTF policies are applicable to drugs, biologies, and certain medical device applications, and the basis for refusal of an application are similar across the products. Below are some examples of reasons why the FDA has invoked the RTF policy for a new drug product. 

EnPol from Korea s IRe Chemicals are based on a group of aliphatic co-polyesters comprising adipic acid, succinic acid, 1,2-ethanediol or 1,4-butanediol. EnPol polymers meet the specifications of the US Food Drug Administration for food contact applications and the USP specifications for medical device applications. 

Enforce Laws and Regulations That Protect Health and Ensure Safety. This service involves full enforcement of sanitary codes, especially in the food industry full protection of drinking water supplies enforcement of clean air standards timely follow-up of hazards, preventable injuries, and exposure-related diseases identified in occupational and community settings monitoring quality of medical services (e.g., laboratory, nursing homes, and home health care) and timely review of new pharmacologic, biologic, and medical device applications. 

ISO 14971 (2000), Medical Devices — Application of Risk Management to Medical Devices. 

International Organization for Standardization. EN ISO 14971 2012. Medical devices. Application of risk management to medical devices. 2012. 

ISO 62366 2007 Medical devices - Application of usability engineering to medical devices [12] is a design and development standard which is harmonised with medical device compliance requirements in many territories. It is closely aligned to risk management standard ISO 14971 2012, essentially ISO 62366 explores in greater depth those hazards which arise from a product s usabifity characteristics. Whilst intended as a standard to support the manufacture of medical devices it contains a useful framework that could be utilised by manufacturers of general HIT products where the user interface is associated with a number of important safety related hazards. 

International Organization for Standardization. lEC 62366 2007. Medical devices - application of usability engineering to medical devices. 2007. 

Cook, A.M. 1982. Sensory and communication aids. In AM. Cook and J.G. Webster (Eds.), Therapeutic Medical Devices Application and Design, pp. 152 201. Englewood ChlFs, NJ, Prentice-HalL Fonda, G.E. 1981. Management of Low Vision. New York, Thieme-Stratton. 

Biocompatibility is a very critical, basic safety requirement for medical polymers in medical device applications. For this, it is essential that ... 

Sastri, V., Plastics in Medical Devices. Chapter 5. Polymer Additives Used to Enhance Material Properties for Medical Device Application. Elsevier, 2010. 

A. Lozano-Morales, H. Garich, L. Gebhart, P. Miller, M. Inman and E.J. Taylor, ECM Surface Engineering Finishing for Medical Device Applications, ASM Materials and Processes for Medical Devices (MPMD) (2007). 

With tunable properties and the ability to create anisotropic orientation-dependent mechanical properties, PVA-C and its composites are suitable candidate materials for medical device application. In this section, we will focus on the use of PVA-C in cardiovascular devices, including vascular grafts and heart valves, and in orthopedic devices, including cartilage and intervertebral discs. 

For medical device application of PVA-C, it is certainly important that its mechanical properties closely match the tissue it is replacing and are compatible with the tissue environment it is implanted into. However, for cardiovascular devices, which... 

PVA is a well-known biocompatible material that can be chemically crosslinked into a hydrogel with many demonstrated biomedical applications. When it is physically crosslinked into PVA-C using the freeze-thaw cycling process, the resulting hydrogel (cryogel) possesses additional characteristics such as nontoxicity and tunable mechanical properties. The anisotropic PVA-C has mechanical properties that closely match those of the natural soft tissue, including orientation. These additional characteristics make it an especially attractive candidate material for medical device applications. 

Over 65% of the global production of BPA is used to make PC and another 30% for epoxy resin production (Plastics Europe, 2010). Based on the 2010 data, however, only 7% of the PC was used in packaging and medical device applications. Most are instead used in construction as glazing or in media (CD and DVD applications) and in electrical/electronic applications. These non-packaging uses pose a lower risk. About a third of this global production is used in the United States. BPA is perhaps the most controversial of plastic-related EDCs present in the environment and is attributed to at least the following sources (Geens et al., 2011). 

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