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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - Mobile Medical Applications Draft Guidance, September 12-13, 2011

The Food and Drug Administration (FDA) held a public Workshop on Mobile Medical Applications Draft Guidance. The U.S. Food and Drug Administration on July 19, 2011 announced it is seeking input on its 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. Through this draft guidance the FDA defined a small subset of mobile medical apps that may impact on the performance or functionality of currently regulated medical devices and as such, will require FDA oversight.

This workshop provided a forum for discussion with FDA and to encourage public comment from interested stakeholders on the following topics:

  • aspects of draft guidance document entitled “Mobile Medical Applications”
  • how the Agency should approach accessories and particularly mobile medical applications that are accessories to other medical devices; and
  • Standalone software that provides clinical decision support.

The FDA encourages feedback from manufacturers, health care providers and others on how its proposal may support the balance between promoting innovation and assuring safety and effectiveness. Submit either electronic or written comments on the draft guidance by October 19, 2011.

Submit electronic comments on the draft guidance to http://www.regulations.gov.

Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.Identify comments with the docket number [Docket No. FDA-2011-D-0530].


Date, Time and Location

This meeting was held on one full day (8:00 am – 6:00 pm) on September 12, 2011, and one half day (8:00 am – 1:00 pm) on September 13, 2011 at the following location:

FDA White Oak Campus
10903 New Hampshire Ave
The Great Room (Room 1503), White Oak Conference Center, Bldg 31
Silver Spring, MD, 20903

Agenda

Day 1 – September 12

TimeDescription
7:30 AMRegistration/Doors Open
8:00 AM-8:15 AMWelcome / logistics / setting the stage for the workshop
8:15AM-8:30 AMKey Note Presentation – Dr. William Maisel, Food and Drug Administration
 
 Session 1 --
8:30 AM-8:45 AMSession Overview – Draft Mobile app guidance – intent and approach
Bakul Patel, Food and Drug Administration
8:45 AM-9:45 AMPANEL 1 - "Mobile medical app" definition
  • Is the subset of mobile medical apps identified in the definition appropriate for FDA oversight?
  • Are there mobile medical apps outside of the defined subset present greater risk (now and in the future)?
  • How best can we define this subset to provide clarity for folks who are innovating in this space?
Moderator: Bakul Patel, Food and Drug Administration
Grant Elliott, Voxiva
Leslie Kelly Hall, Healthwise
Kerry McDermott, West Wireless Health Institute
Dave Eichler - Psilos Group
Dane Stout , Anson Group
Brian Dolan, MobiHealth News
9:45 AM-10:00 AMQ/A audience interaction
10:00 AM-10:15 AMBreak
10:15 AM-11:15 AMPanel 2 -- Level of oversight and proposed approach --  following current classifications and oversight controls.
  • Is the level of oversight appropriate for mobile apps?
  • What part of current requirements needs clarity for mobile medical apps?
  • Is there a different general approach to effectively oversee mobile medical apps?
  • Are there other factors to be considered in effectively assuring safety of mobile medical apps?
  • How best can the guidance provide more clarity to mobile medical app manufacturers?
Moderator: Anthony Watson, Food and Drug Administration
Dr. Anand Iyer, Well Doc Inc.
Dr. David S. Hirschorn, American College of Radiology
Robert Jarrin, Qualcomm Inc
Bernie Liebler, Advamed
Kent Dicks, MedApps Inc
Scott Thiel, Anson Group
11:15 AM-11:30 AMQ/A audience interaction
11:30 AM-12:00 PMPublic presentations -- Open Public comments (5 minutes max – no powerpoint)
12:00 PM-1:00 PMLunch
 Session 2 --
1:00 PM-1:15 PM

Session overview: Mobile medical apps as accessories to medical devices -- how the Agency should approach accessories in the context of mobile medical applications that are accessories to other medical devices

Proposed approach --

  1. An accessory that does not change the intended use of the connected device, but aids in the use of the connected medical device could be regulated as class I.
  2. An accessory that extends the intended use of the connected medical device could be classified with the connected device.
  3. An accessory that creates a new intended use from that of the connected device(s) could be classified according to the risk posed to patient safety by the new intended use.

- Bakul Patel, Food and Drug Administration

1:15 PM-1:30 PMPanel 3 – Current and future trends in connecting accessories to medical devices
  • Commercial technologies, such as smart phones, are being used as an accessory to medical devices to deliver medical information to users. What current and future connectivity trends does FDA need to be aware of to formulate an appropriate oversight approach?
  • What role does infrastructure play in the medical use of mobile medical apps?
  • How connectivity to medical devices can allow mobile medical apps to be used as accessories to the primary device regulated by FDA.
Moderator: Bryan Benesch, Food and Drug Administration
Bradley Thompson, EpsteinBeckerGreen Law
Chuck Parker , Continua Health Alliance
Jorge Valdes, Dexcom
Dr, Neal Sikka, George Washington University
Marc Anderson, Juvenile Diabetes Research foundation (JDRF)
1:30 PM-2:15 PMQ/A audience interaction
2:15 PM-2:30 PMBreak
 Panel 4 - Approach and level of oversight for mobile medical apps which become accessories to multiple medical devices --
  • When a mobile app is an accessory for various devices with different classifications, is the proposed approach appropriate to assure safety and effectiveness?
  • What are some alternate approaches that provide the right level of oversight?
  • How do we assure the device functionality is not affected?
  • Can compatibility of accessories developed by a 3 rd party be assured for patient safety?
Moderator: Bakul Patel, Food and Drug Administration
Bradley Thompson, EpsteinBeckerGreen Law
Chuck Parker , Continua Health Alliance
Dr. Joseph Smith, West Wireless Health Institute
Dr. Donna-Bea Tillman, Microsoft Health Solutions Group
John LaLonde, Boston Scientific
2:45 PM-3:30 PMQ/A audience interaction
3:30 PM-3:45 PMOpen public comments -- (5 minutes max – no power-point presentation)
4:30 PMEnd of Day 1

Day 2 – September 13

TimeDescription
7:30 AMDoors open
 Day 2 kick-off / Session 3
8:15 AM-8:30 AMSession overview -- Bakul Patel, Food and Drug Administration
8:30 AM-9:30 AMPresentations – (10 minutes each)
  • Definition of stand-alone CDS software
  • What are the different types of CDS software?
  • What levels of support do these CDS software provide?
Speakers:
Dr Kristen Meier, Food and Drug Administration
Dr. Jonathan P. White, Agency for Healthcare Research and Quality Health
Dr. Stan Pestotnik, TheraDoc Clinical IT
Dr. Richard J. Katz, George Washington University
Dr. Meghan Dierks, Beth Israel Deaconess Medical Center
Meryl Bloomrosen, American Medical Informatics Association (AMIA)
9:30 AM - 10:00 AMQ/A audience interaction
10:00 AM -10:15 AMBreak
10:15 AM-11:30 AMPanel 5 - Categorizing standalone clinical decision support software
  • What factors should FDA consider in determining the risk classification of different types of software that provide CDS?
  • What is an appropriate approach for assessing reasonable safety and effectiveness of these types of software for each of these factors?
Moderator: Dr. Meghan Dierks, Beth Israel Deaconess Medical Center
Dr. Jonathan P. White, Agency for Healthcare Research and Quality Health
Stan Pestotnik, TheraDoc Clinical IT
Dr. Richard J. Katz, George Washington University
Dr. Satish Misra, iMedical apps
Dr. Michael Segal, SimulConsult
Dr. Wendy J. Nilsen, National Institute of Health
Meryl Bloomrosen, AMIA
11:30 AM-12:00 PMQ/A audience interaction
12:00 PM-12:45 PMOpen public comments -- (5 minutes max – no power-point)
12:45 PM-Wrap up/Adjourn
1:00 PMEnd of Public meeting

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Transcripts

Contact Us

For information regarding the program, contact:

Bakul Patel
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, Bldg 66
Silver Spring, MD 20993
Phone: 301-796-5528
Email: Bakul.patel@fda.hhs.gov