WebWhen shooting on an Alexa Mini or Alexa Mini LF you basically have two recording options, ProRes and ARRIRAW. When you shoot ARRIRAW you can choose to enable HDE via Codex Device Manager. When HDE is enabled the mag will mount as ‘A013_hde’, when HDE is disabled the mag will mount as ‘A013’. Humanitarian Use Device (HUD): a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year (Section 3052 of the 21st Century Cures Act (Pub. L. No. 114-255). Humanitarian Device … See more The Food and Drug Administration Amendments Act of 2007 (FDAAA) contained incentives to facilitate development of medical devices for pediatric populations … See more The number of HDE devices that may be sold for profit is limited to a quantity known as the Annual Distribution Number (ADN). If the FDA determines that an HDE … See more
Humanitarian Device Exemption FDA
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