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Hornback is a compliance consultant at KMI/Parexel LLC (Alpharetta, GA). Stability is defined as “the extent to which a product retains, within specified limits and throughout its period of storage and use (i.e., its shelf life), the same properties and characteristics that it possessed at the time of manufacture.”1 According to FDA regulations, IVD reagents and consumables marketed in the U. For example, the Code of Federal Regulations (CFR) states that “the basis for such instructions (e.g., those needed to protect the stability of the product) shall be determined by reliable, meaningful, and specific test methods.”2 IVDs approved by the Center for Biologics Evaluation and Research (CBER) are also subject to other CFR requirements, which state that an application for a biological license shall include “data establishing stability of the product through the dating period.”3 While a significant number of guidance documents directly relate to the requirements for stability testing of drugs, guidance regarding stability testing of medical devices in general and IVDs in particular is limited.1, 4, 5, 6 This article discusses the various aspects unique to stability testing of IVDs and offers suggestions on how to optimize the design of stability studies.
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SUMMARY: Maryland Traffic Tickets Depending on where you received your MD traffic ticket, you can pay your ticket fines online, by mail, in person, or by phone.
Be sure to take action within 30 days of receiving your citation. To fight your ticket, you can plead “not guilty" by mail.
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