Mobile Medical Apps Supervision By FDA, Agency Seeking Input
Editor's ChoiceMain Category: IT / Internet / E-mail
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Jul 2011 - 6:00 PDT
'Mobile Medical Apps Supervision By FDA, Agency Seeking Input'
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As more and more mobile medical apps (applications) enter the market, the FDA (Food and Drug Administration) has said today it seeks feedback on its proposed oversight approach. These apps are designed for smartphone and other mobile computing device usage.
The FDA says it would like to focus just on a certain number of apps and will not become involved in regulating apps for consumer use.
Mobile medical apps have a variety of functions today, including helping people maintain a healthy body weight, keeping an eye on their calorie consumption, or allowing physicians to see a patient's imaging scans on a mobile device. By 2015 over 500 million smartphone users are expected to be using a health care app.
Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, said:
"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery. Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don't work as intended."
The FDA would like to supervise a small subset of mobile medical apps that might impact the functionality or performance of currently regulated medical devices. For example:
- Apps that are currently used as an accessory to already FDA-regulated medical devices. These may include apps that allow a doctor to view a scanned image from a PACS (archiving communication system) on a smartphone or mobile tablet.
- Apps that can turn a mobile communications device into an FDA-regulated medical device by using sensors, attachments or other devices. For example, some smartphones can turn into an ECG device.
The Agency says it will update the draft guidance according to feedback it receives.
"FDA: Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications"
"FDA: Consumer Update - FDA Proposes Health 'App' Guidelines"
Written by Christian Nordqvist
Copyright: Medical News Today
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Visitor Opinions (latest shown first)
Fiscally Irresponsible
posted by Jesse_EngAmer on 26 Jul 2011 at 11:28 amMore fiscally irresponsible regulation from the FDA. Big surprise.
Medical apps are a small proportion of our medical devices. 50% of our medical devices and 80% of our pharmaceuticals are imported according to the FDA themselves in their report Pathway to Global Product Safety and Quality. They also said themselves that “The safety of America’s food and medical products remains under serious threat… it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority.” The FDA is lacking in resources and manpower. The FDA’s budget was slashed recently by 258 million. This new set of regulations is only one instance of new regulations that are taking away resources from more important areas. This lack of resources has made the 2011 Food Safety and Modernization Act reactionary instead of preventative as the FDA will need to establish a myriad of partnerships, coalitions and improved intelligence-gathering techniques. Even then, resources will still be deployed on “data-driven risk analytics.” Hardly all-inclusive, hardly preventative. By overregulating this new field of technology and handing over monopolies to big pharma, we crush innovation. Many companies, especially small tech startups cannot afford the increased research. For example since 1968 about 41 less new pharmaceuticals have been approved each year according to the Independent Institute and even more aren’t even researched due to the costs associated.
Initially, for the first 86 years of FDA's existence, from 1906-1992the U.S. treasury department funded the FDA. In 1992 a law passed allowing pharmaceutical companies to provide funding for their own research that smaller companies could not put forth.
Once again the FDA kills growth and initiative in favor of Big Pharma.
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