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The PMA process typically takes more than a year and requires the submission of significant quantities of clinical data and supporting information, while the process of obtaining a 510(k) clearance typically takes less than one year and involves the submission of less clinical data and supporting information. An entity must file with the FDA even if the device is simply a quot;new devicequot; to the particular entity, and is otherwise a well known device in the marketplace. Since the Symdex 1500, NPTR Test and Sleep Monitor, if they achieve commercial viability, will be introduced into commerce within the United States for the first time by the Company, each will be considered a quot;new devicequot; under FDA regulations and will require appropriate filings with the FDA. The FDA has already classified and approved other depth of anesthesia devices and impotence diagnostic tools, that the Company believes are substantially equivalent to the Symdex 1500, NPTR test and Sleep Monitor as Class II medical devices.]