Definition Edit

A mobile medical app manufacturer is

any person or entity that manufactures mobile medical apps in accordance with the definitions of manufacturer in 21 CFR Parts 803, 806, 807, and 820.7. A mobile medical app manufacturer may include anyone who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components.[1]

Overview Edit

"This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include owners and operators of "Google play," "iTunes App store," and "BlackBerry App World."[2]

References Edit

  1. Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff, at 9.
  2. Id.

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