Mobile Medical Applications

Information about Mobile Medical Applications

Published on September 2, 2014

Author: praveen114731

Source: authorstream.com

Content

Mobile Medical Applications: Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff : Guidance for Industry and Food and Drug Administration Staff Introduction The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential benefits and risks to public health represented by these apps. The FDAs issuing this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority. PowerPoint Presentation: Many mobile apps are not medical devices (meaning such mobile apps do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them. Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act). The majority of mobile apps on the market at this time fit into these two categories PowerPoint Presentation: Consistent with the FDA’s existing oversight approach that considers functionality rather than platform , the FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.This subset of mobile apps the FDA refers to as mobile medical apps. PowerPoint Presentation: FDA is issuing this guidance to provide clarity and predictability for manufacturers of mobile medical apps. Should FDA determine at a later date that the policy in this guidance should be changed in light of new information, the agency would follow a public process, including the opportunity for public input, consistent with FDA’s good guidance practices (GGP) regulation in 21 CFR 10.115 PowerPoint Presentation: FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities . Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations , unless specific regulatory or statutory requirements arecited . The use of the word should in Agency guidances means that something is suggested or recommended , but not required.

Related presentations


Other presentations created by praveen114731

Purva Palm Beach Cheat
01. 08. 2014
0 views

Purva Palm Beach Cheat

Purva False Commitment
02. 08. 2014
0 views

Purva False Commitment

Purva Palm Beach Complaint
04. 08. 2014
0 views

Purva Palm Beach Complaint

anil sharma cmd amrapali group
06. 08. 2014
0 views

anil sharma cmd amrapali group

Sanjeev ghai Income Tax
09. 08. 2014
0 views

Sanjeev ghai Income Tax

sanjeev ghei
30. 08. 2014
0 views

sanjeev ghei

Eschol Tech Solutions
09. 09. 2014
0 views

Eschol Tech Solutions

Purva Eternity Delay
09. 09. 2014
0 views

Purva Eternity Delay

Sanjeev ghei, sanjeev ghai
24. 09. 2014
0 views

Sanjeev ghei, sanjeev ghai

Olumide C
07. 10. 2014
0 views

Olumide C

Sanjeev ghai, Sanjeev ghai
09. 10. 2014
0 views

Sanjeev ghai, Sanjeev ghai

Olumide pidan D
13. 10. 2014
0 views

Olumide pidan D

Olumide pidan E
13. 10. 2014
0 views

Olumide pidan E

Sanjeev ghai Income tax B
13. 10. 2014
0 views

Sanjeev ghai Income tax B

Sanjeev ghai Income tax A
13. 10. 2014
0 views

Sanjeev ghai Income tax A

Sanjeev ghai Income tax C
13. 10. 2014
0 views

Sanjeev ghai Income tax C

Sanjeev ghei 3
28. 10. 2014
0 views

Sanjeev ghei 3

Sanjeev ghai 1
28. 10. 2014
0 views

Sanjeev ghai 1

Sanjeev ghai irs 2
28. 10. 2014
0 views

Sanjeev ghai irs 2

Sanjeev ghai income tax 4
28. 10. 2014
0 views

Sanjeev ghai income tax 4

Sanjeev ghai irs 13
29. 10. 2014
0 views

Sanjeev ghai irs 13

Sanjeev ghei 11
29. 10. 2014
0 views

Sanjeev ghei 11

Sanjeev ghai income tax 12
29. 10. 2014
0 views

Sanjeev ghai income tax 12

Sanjeev ghai 12
29. 10. 2014
0 views

Sanjeev ghai 12

Figurative-Language-6227368
01. 11. 2014
0 views

Figurative-Language-6227368

Forex-Triple-B-6915310
01. 11. 2014
0 views

Forex-Triple-B-6915310

Olumide pidan @ 1
05. 11. 2014
0 views

Olumide pidan @ 1

Sanjeev ghai irs 2001
06. 11. 2014
0 views

Sanjeev ghai irs 2001

Sanjeev ghei 2011
06. 11. 2014
0 views

Sanjeev ghei 2011