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This presentation looks at some of the unique considerations in developing mobile programs, especially apps. A significant amount of the presentation is dedicated to elucidating and expanding on the ...

This presentation looks at some of the unique considerations in developing mobile programs, especially apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps.

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The Move to Mobile The Move to Mobile Presentation Transcript

  • The Move to Mobile: Strategies to Mitigate Regulatory Concerns for Digital Platforms Presented by Dale Cooke 8 October 2013
  • 2 Medical DevicesAdvertising & Promotion What is this thing?
  • 3 FDA is here to help http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidan ce/GuidanceDocuments/UCM263366.pdf See also, http://www.scribd.com/doc/170875173/DH-Regulatory-Alert- Mobile-App-Guidance-Finalized Released September 2013 View slide
  • 4 MMA guidance Mobile Medical App (MMA) defined as: “a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and either is intended: • to be used as an accessory to a regulated medical device; or • to transform a mobile platform into a regulated medical device.” —FDA Guidance for Industry: Mobile Medical Applications, page 7 View slide
  • 5 CDRH regulatory focus CDRH will focus its regulatory efforts on apps that: > Are accessories to a regulated medical device > Transform the mobile device into a medical device > Perform patient-specific analysis and provide patient- specific treatment recommendations
  • 6 CDRH regulatory discretion “Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act)” —FDA Guidance for Industry: Mobile Medical Applications, page 4 Requirements of the FD&C Act include: > Registration as a medical device manufacturer > Premarket submission/approval > Filing Medical Device Reports (MDRs)
  • 7 Will FDA change its position? —FDA Mobile Apps Twitter Chat, September 26, 2013
  • 8 Scope of the discretion • Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions; • Provide patients with simple tools to organize and track their health information; • Provide easy access to information related to patients’ health conditions or treatments; • Help patients document, show, or communicate potential medical conditions to health care providers; • Automate simple tasks for health care providers; or • Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems. —FDA Guidance for Industry: Mobile Medical Applications, page 16
  • 9 What about dosing apps? “apps that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy” ARE devices where FDA will require presubmission, etc. But… “Mobile apps that perform simple calculations routinely used in clinical practice” ARE devices where FDA will NOT require presubmission, etc. —FDA Guidance for Industry: Mobile Medical Applications, page 15 —FDA Guidance for Industry: Mobile Medical Applications, page 17
  • 10 Some will not be subject to enforcement
  • 11 > Class determination > Development environment > 510(k) or PMA filing with FDA likely required > Medical device manufacturer registration > Postmarketing reporting requirements Meeting medical device requirements
  • 12 Promotional labeling requirements Product Promotion Requirements > Product Name Usage > Fair Balance > Indication Statement > Adequate Provision (Directions for Use) > MedWatch Statement > Beware turning your app into a regulated device via promotion! Four Types of Communication > Reminder Ads > Product Promotions > Disease Awareness Communications > Redirecting Communications
  • 13 But what about mobile promotion? Unique considerations for mobile promotion > Device size > Device variability > Screen rotation > Technology changes (Go away, Flash!) > Screen takeover > Touch screen interface > Integration with the rest of the device (GPS, calendar, reminders, etc.)
  • Questions? Dale Cooke Vice President/Group Director, Regulatory Review Dale.Cooke@DigitasHealth.com @PhillyCooke on Twitter www.scribd.com/Dale_Cooke
  • 15 Dale Cooke VP/Group Director, Regulatory Review Dale Cooke is the head of the regulatory department for Digitas Health. He has worked with more than 30 pharmaceutical and medical device clients and with Medical-Legal-Regulatory committees around the world from offices in Philadelphia, New York, Boston, San Francisco, and London. Dale advises clients on FDA enforcement actions and provides recommendations for compliance with FDA regulations, with a focus on issues involving the Internet and emerging technology. His insights have been featured in the Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), and the Food and Drug Law Institute (FDLI). Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of the FDLI primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and pharmaceutical involvement in social media. Dale earned his B.A. in Philosophy from Southern Methodist University and an M.A. in Analytical Philosophy from the University of Arizona and studied Epidemiology and Biostatistics at Drexel University’s School of Public Health.