Navigation Links
FDA Outlines Oversight of Mobile Medical Applications
Date:7/19/2011

SILVER SPRING, Md., July 19, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications ("apps") that are designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Today, mobile medical applications or "mobile medical apps," include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient's radiology images on their mobile communications device. According to Research2Guidance 2010, 500 million smartphone users worldwide will be using a health care application by 2015.

"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "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The agency's draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:

a. are used as an accessory to medical device already regulated by the FDA
(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system(PACS) on a smartphone or a mobile tablet); or

b. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices
(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).

The agency is seeking public input on this approach. Once posted, comments can be submitted for 90 days online or in writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD  20852. The FDA will update the guidance based on feedback received.

For more information:
FDA: Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Amanda Sena, 301-796-0393, amanda.sena@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Lilly Outlines For Investors How Its Innovation-Based Strategy and Robust Pipeline Will Drive Future Growth Following Upcoming Patent Expirations
2. Oclaro Provides Complete Fiber Laser Diode Solutions Portfolio; Outlines Future Innovation and Technology Advancements
3. Amgen Outlines Strategy, Growth Objectives and Capital Allocation Plans
4. Mithridion, Inc. Announces New Funding and Outlines Strategy for Central Nervous System Drug Development
5. Medical Affairs Report Outlines Resource Needs for Group Success
6. Alexza Pharmaceuticals Updates Staccato® Pipeline and Outlines Pipeline Development Strategy
7. Solos Endoscopy, Inc. Outlines Marketing Strategy for 2010 Campaign
8. Lilly Outlines Innovation Strategy, Reviews Promising Pipeline of Potential Medicines and Sets 2010 Financial Guidance
9. Is Poor Medical Equipment Planning Costing your Healthcare Project Wasted Dollars and Delays? ECRI Institute outlines best practices to ensure better outcomes
10. Bob McDonald Outlines Key Long Term Growth Strategies To P&G Shareholders
11. Consensus Document Outlines Practical Steps for Reducing Gastrointestinal Risks of Antiplatelet and NSAID Use
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... India , May 25, 2016 ... Review, H1 2016"market research report that provides an ... with comparative analysis at various stages, therapeutics assessment ... of administration (RoA) and molecule type, along with ... It also reviews key players involved in the ...
(Date:5/24/2016)... , May 24, 2016   ... demonstrating non-inferiority in overall bowel cleansing and superiority in ... c leansing of the ... ) , Norgine B.V. today announced new positive ... PEG and ascorbate bowel preparation) versus standard 2 litre PEG with ...
(Date:5/24/2016)... 2016 Celsion Corporation (NASDAQ: ... provided an update on its ongoing OVATION study, ... GEN-1, the Company,s DNA-based immunotherapy, with the standard ... with advanced ovarian cancer who will undergo neoadjuvant ... an IL-12 DNA plasmid vector formulated as a ...
Breaking Medicine Technology:
(Date:5/25/2016)... ... May 25, 2016 , ... America Walks , a ... M.S.L., M.S.P.A., of the University of Pittsburgh Graduate School of Public Health , ... Ms. Reichbaum and 24 other advocates from around the country to participate in a ...
(Date:5/25/2016)... ... May 25, 2016 , ... Laser Skin & Wellness Center is ... of time of female aging. The Julietâ„¢ procedure helps to reverse ... as leakage, laxity, itchiness and pain have reported real relief from these and other ...
(Date:5/25/2016)... ... May 25, 2016 , ... BeniComp Insurance Company, a leading ... their clients' employee participation for their wellness initiatives. BeniComp clients experience nearly ... health plan with outcome-based deductible incentives. As a result, BeniComp clients have been ...
(Date:5/25/2016)... ... ... Consumer access to organic foods and grower access to food processers is ... cereals and other plant-based foods, will introduce the first consumer product (a new breakfast ... Hesco/Dakota Organic Products. , The transitional designation means the cereal was made using at ...
(Date:5/25/2016)... ... May 25, 2016 , ... HealthPostures , a national ... leading engineers at the American Society of Safety Engineers Conference in Atlanta, Georgia. ... , Engineers, speakers and exhibitors from more than 40 countries are scheduled to ...
Breaking Medicine News(10 mins):