FDA's Legal Hold on Your Mobile Apps
April 14, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
Phone:8004479407
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Overview: The use of mobile apps has increased dramatically year after year. The sophistication of the platform technology, e.g., cell phone, creates huge opportunity for software application. A sensor plugged into your cell phone can be used as a stethoscope. How the platform and software are integrated becomes a significant regulatory issue for the FDA. In addition to an app being safe and effective, this type of device requires the design and implementation of preventive measures to ward off cyber-intrusions. The portals of attack with the use of mobile apps and wireless technology have become an attractive invitation for hackers. This is something even the FBI worries about and has told firms as such apart from the FDA's regulatory charge. General regulatory controls can be applied to mobile apps, some more so than others. Depending on the intended use of the app it may be subject to special controls or exhaustive scientific and clinical study before it may be marketed legally. Understanding the FDA's regulatory approach to the use of apps can become the ultimate and fatal hack on your business if you do not understand your FDA obligations Why should you Attend: The regulation of software by the FDA can hardly be seen as timely, sufficient or clear. Mobile medical apps are the new kid on the block and face an uncertain regulatory future. Mobile apps may or may not be exempt from premarket authorization, but in any case are subject design controls under the Quality System regulation. FDA can conduct an inspection of the software developer/manufacturer and go through its design control procedures and dossier. Are you ready? The FDA may say your update to an app is a recall. You should be ready to submit the information required by the Corrections and Removals regulation and ensure you have an adequate Corrective and Preventive Action (CAPA) program. Firms will receive a Warning Letter if they have not established and implemented a CAPA program. The same is true for required reporting for adverse event and recalls. Mobile apps raise special concerns about cybersecurity due to their reliance on wireless technology. Users may not, and probably do not, appreciate the vulnerabilities they have when using mobile apps. The software may be corrupted and performance functions changed, or a device can simply be shut it down. App users may not understand vulnerabilities in the use of network or public communication servers. You as a manufacturer are responsible for addressing these kinds of issues before you let someone download your app. Areas Covered in the Session: What is an app? Scope of mobile app use Design control obligations Hazards and risks assessment Recalls and Corrective and Preventive Actions Cybersecurity and damage control Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1ME4tje support@compliance4all.com www.compliance4all.com