MHealth Regulation

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Background

The Food and Drug Administration (FDA) FDA first issued draft guidance "Policy for the Regulation of Computer Products" in 1989[1][2]. The guidance was never finalized and instead retracted in 2005[1][2]. It wasn't till February 15, 2011 that the FDA issued a regulation regarding computer and software that could transfer, store, display, or convert medical device data[2]. The FDA later issued specific guidance for MHealth applications on September 25, 2013 which has been replaced by updated guidance on February 9, 2015[2].

MHealth Applications defined

The FDA guidance describes regulated applications as "meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)[3]< and either is intended: to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device."[2].

Exemptions

References

  1. 1.0 1.1 IT Law Wiki Page on 1989 draft policy
  2. 2.0 2.1 2.2 2.3 2.4 2015 Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff - issued February 9, 2015
  3. Section 201 of FD&C Act

Submitted by (Eric J. Vinson)