DEVICE APPROVAL PROCESS
\dɪvˈa͡ɪs ɐpɹˈuːvə͡l pɹˈə͡ʊsɛs], \dɪvˈaɪs ɐpɹˈuːvəl pɹˈəʊsɛs], \d_ɪ_v_ˈaɪ_s ɐ_p_ɹ_ˈuː_v_əl p_ɹ_ˈəʊ_s_ɛ_s]\
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Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.
By DataStellar Co., Ltd
Word of the day
Platidiam
- An inorganic water-soluble platinum complex. After undergoing hydrolysis, it reacts DNA produce both intra interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity cisplatin correlates with cellular arrest in G2 phase cell cycle.