Difference between revisions of "MHealth Regulation"
Line 1: | Line 1: | ||
== 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− | The Food and Drug Administration (FDA) [http://http://www.fda.gov/ FDA] first issued draft guidance "Policy for the Regulation of Computer Products" in 1989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="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" />. | + | The Food and Drug Administration (FDA) [http://http://www.fda.gov/ FDA] first issued draft guidance "Policy for the Regulation of Computer Products" in 1989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" />. 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<ref name="FDA2015" />. The FDA later issued specific guidance for [[MHealth]] applications on September 25, 2013 which has been replaced by updated guidance on February 9, 2015<ref name="FDA2015" />. |
+ | |||
+ | == [[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)<ref name="FDC">[http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.htm Section 201 of FD&C Act]</ref>< 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."<ref name="FDA2015" />. | ||
== Exemptions == | == Exemptions == |
Revision as of 02:40, 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The Food and Drug Administration (FDA) FDA first issued draft guidance "Policy for the Regulation of Computer Products" in 1989[1][2].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]. 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
- ↑ 1.0 1.1 IT Law Wiki Page on 1989 draft policy
- ↑ 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
- ↑ Section 201 of FD&C Act
Submitted by (Eric J. Vinson)