Use Of Testing For Medical Devices Essay

1462 Words Nov 24th, 2016 6 Pages
If the NDA is approved, the drug developer is able to work with the FDA to finalize production (or continue/update research, requiring new INDs/NDAs) before it is marketed to the public and prescribed by relevant authorities for implementation. Furthermore, the FDA continues to monitor manufacturing facilities and instructs the developer on marketable information [2]. In practice, this process takes upwards of fifteen years, much longer than most devices would require. According to JoAnn Schuh, Ph.D., a consultant for drug development, testing for medical devices begins with toxicity, not candidacy or discovery. Bioelectronic devices, being surgically implantable, therefore require more strenuous and lengthy testing. Additionally, since bioelectronic devices are comprised of multiple components with different chemical makeup and function, each component is usually tested individually and finally together as they would be assembled for a final product. Similar to pharmaceuticals, testing for bioelectronic devices involves in vitro and in vivo approaches, the former using assays and the latter involving animals. Unlike drugs, bioelectronic devices do not utilize rodents for animal testing, but instead larger animals such as monkeys, rabbits, dogs, or goats, etc. If the device is determined not to cause irritation or is toxic to various biological functions, induced or simulated disease testing in animals is completed properly, and is shown to be compatible with the body…

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