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Certified Pure Materials: Expedite FDA Approvals for Medical Devices

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A key focus of the U.S. Food and Drug Administration’s evaluation of a medical device’s safety and effectiveness is reviewing its material makeup. If improperly tested – and impure materials are used - there is an elevated risk of contamination that can produce false results. The already lengthy FDA approval process for medical device manufacturers can be extended dramatically without certified pure materials, which will, in turn, increase the cost of commercialization. When considering materials for functional applications including filtration, venting, wicking, applying, and absorbing, manufacturers should consider those materials already third-party tested to stringent analytical, clinical, and life science procedures.

In this tech brief written for medical device engineers and researchers, learn what third-party material purity tests are associated with each FDA application tier so that manufacturers can enable a faster device market launch. The brief describes each of the relevant third-party tests and how you can determine the right level of purity needed for your type of medical device, along with what types of high-purity porous materials can be used. Third-party testing includes leachables and extractables, as well as viral and bacterial filtration efficiency.


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