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Citation[]

Food and Drug Administration, FDA Policy for the Regulation of Computer Products (draft) (Nov. 13, 1989) (full-text).

Overview[]

"After 1989, however, the use of computer and software products as medical devices grew exponentially and the types of products diversified and grew more complex (and that trend has continued). As a result, the FDA determined that the draft policy did not adequately address all of the issues related to the regulation of all medical devices containing software. Therefore, in 2005, the Draft Software Policy was withdrawn."[1]

References[]

  1. See Annual Comprehensive List of Guidance Documents at the Food and Drug Administration, 70 Fed. Reg, 824, 890) (Jan. 5, 2005).

Source[]

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