Difference between revisions of "MHealth Regulation"
From Clinfowiki
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== Background == | == Background == | ||
| − | The Food and Drug Administration (FDA) [http://http://www.fda.gov/ FDA] first issued draft guidance "Policy for the Regulation of Computer Products" in 1989<ref name="FDA2015">[http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf 2015 Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff - issued February 9, 2015]</ref>. | + | The Food and Drug Administration (FDA) [http://http://www.fda.gov/ FDA] first issued draft guidance "Policy for the Regulation of Computer Products" in 1989<ref name="wiki1989">[http://itlaw.wikia.com/wiki/FDA_Policy_for_the_Regulation_of_Computer_Products IT Law Wiki Page on 1989 draft policy]</ref><ref name="FDA2015">[http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf 2015 Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff - issued February 9, 2015]</ref>. The guidance was never finalized and instead retracted in 2005<ref name="wiki1989" /><ref name="FDA2015" />. |
== Exemptions == | == Exemptions == | ||
Revision as of 02:23, 29 April 2015
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The Food and Drug Administration (FDA) FDA first issued draft guidance "Policy for the Regulation of Computer Products" in 1989[1][2].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].
Exemptions
References
- ↑ 1.0 1.1 IT Law Wiki Page on 1989 draft policy
- ↑ 2.0 2.1 2015 Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff - issued February 9, 2015
Submitted by (Eric J. Vinson)
