Citation Edit

U.S. Food and Drug Administration, Draft Software Policy (1989) [official known as "Food and Drug Administration, Center for Devices and Radiological Health, FDA Policy for Regulation of Computer Products, Draft" (Nov. 13, 1989).]

Overview Edit

In 1989 the FDA published its "Draft Software Policy." The FDA recognized that software could (and did) meet the definition of a medical device and extended its purview from conventional devices to software. Since 1989, however, the use of computer- and software-based products as medical devices has grown exponentially. Consequently, the FDA determined that because of the history, complexity, and diversity of computer systems and controlling software, it would be impractical to adopt one "software" or "computer" policy to address all computer and software medical devices.

Because the 1989 Draft Policy was never published as final, it had no legal status.

The Draft Software Policy was withdrawn on January 5, 2005.[1]

References Edit

  1. 70 Fed. Reg. 824, 890 (Jan. 5, 2006).

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