FDA issues Guidance on Mobile Medical Apps

FDA LogoWASHINGTON – Sept. 24, 2013 – The American Telemedicine Association (ATA) is encouraged by the Food and Drug Administration’s (FDA’s) release of guidance on mobile medical apps.
[Modern Health Talk is encouraged too.]

“The FDA has chosen wisely to target its strict regulatory efforts on mobile applications that could pose a significant risk to consumers if used improperly.” said Jonathan Linkous, chief executive officer of ATA. “Their regulation will help reassure patients and consumers that mobile health applications are not only convenient, but safe.”

The FDA has tailored their risk-based oversight to regulate mobile medical apps that:

  • Are intended to be used as an accessory to a regulated medical device – such as an application that would allow practitioners to diagnose a patient via images viewed through picture archiving systems or mobile devices; or
  • Have the ability to transform a mobile device into a regulated medical device – such as an application that turns a smartphone into an electrocardiography machine to detect abnormal heart rhythms or a heart attack.

“This regulation is critical to the growth in the use of wireless devices and software.  Providing the FDA’s stamp of approval will provide needed assurance to providers and consumers that telemedicine can help improve quality, access and affordability of care,” said Linkous.

The FDA issued a first draft of the mobile medical application guidance in July 2011 and received over 130 comments. ATA submitted comments and suggestions to the agency on the draft, and is pleased that the final regulation supports risk-based oversight that will not hinder market growth and consumer adoption.

The American Telemedicine Association is the leading international resource and advocate promoting the use of advanced remote medical technologies. ATA and its diverse membership work to fully integrate telemedicine into healthcare systems to improve quality, equity and affordability of healthcare throughout the world. Established in 1993, ATA is headquartered in Washington, DC. For more information visit www.americantelemed.org.

Medical Devices Must Include Identifier Codes

Sept 20 (Reuters) – U.S. regulators on Friday issued a long-awaited rule on Friday requiring companies to include codes on medical devices that will allow the Food and Drug Administration to track devices, monitor them for safety and issue recalls when needed.

The FDA will enter the unique device identifier, or UDI codes, into a database that the agency will maintain as a publicly searchable reference catalogue.

“A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used,” said Dr. Jeffrey Shuren, director of the FDA’s medical device division, in a statement.

The FDA plans to phase in the UDI system, focusing first on medical devices that carry the greatest risk to patients such as pacemakers, defibrillators, heart pumps and artificial joints. Many low-risk devices will be exempt from some or all of the requirements.

The FDA said medical device records will have to include the UDI code. The rule also establishes accreditation requirements for agencies that may operate systems for issuing UDI codes.

2 thoughts on “FDA issues Guidance on Mobile Medical Apps

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  2. Where is mHealth, medical device certainty? 

    In a March 18 letter to FDA Commissioner Margaret A. Hamburg, MD, Senators Michael Bennet (D-CO), Orrin Hatch (R-UT), Tom Harkin (D-IA), Lamar Alexander (R-TN), Mark Warner (D-VA), and Richard Burr (R-NC) ask the FDA to give developers and business ventures the information and clarity they need to avoid confusion about regulatory policies for mobile medical applications.

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