Medical Device Mobile Apps What Needs FDA Approval

Held Aug. 30, 2012

There are 40,000 medical applications available for download on smartphones and tablets — but which ones need FDA approval?

The FDA has proposed policing only those apps that use supplemental attachments to transform a mobile platform into a medical device and others that act as accessories to an already regulated medical device.

But this growth and the FDA’s definitions have created a quagmire for the FDA and industry.  Questions abound:

  1. If your product needs FDA approval, is it a 510k or a full-blown application?
  2. Will the regulations keep up with the lightning-fast app development cycle?  Some have called the FDA’s approval process stuck “in the floppy disk” era.
  3. The FDA mentioned “enforcement discretion” for some apps that might not meet the definition of a covered device app, BUT might be considered a traditional medical device — what does that mean?

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Approved and in-development device apps are announced every day:

  • Smartphone App to Diagnose Pneumonia — Hon Weng Chong, a 24-year-old student at Melbourne Medical School, has developed a quick way to diagnose children in areas where health care is scarce. He's built a stethoscope that can plug into a smartphone and doesn't require medical training to use.
  • The pharmaceutical firm Sanofi has an app for a diabetic that registers glucose levels with the help of a meter that attaches to iPhones.
  • Beam Brush, a smartphone app gained FDA 510(k) clearance — A sensor on board the Beam Brush monitors when and for how long users brush their teeth, and then transmits the data over a Bluetooth connection to a smartphone app.  The app helps with personal management.  Users can forward data to their dentist or hygienist.
  • iHealth offers an app that records blood pressure using a cuff that plugs into an iPhone.
  • Twitter, smartphones help in treating stroke victims — The i-Stroke system transfers hospital-generated patient, clinical and imaging information, including CT scans, MRI results and CT angiograms, from a hospital "stroke server" to a physician's smartphone, which is preloaded with diagnostic-management tools. The consultation occurs via Twitter direct messages, seen only by the message recipient.
  • If AliveCor gets its way, patients may be able to get an EKG by pressing an iPhone to their chest.

But will all of these need FDA approval?  How long will it take, and how much money will it cost, to manage the FDA approval process?  If you have questions, we have answers.

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Featuring four speakers focusing on the trends, FDA regs, best practices for getting approval and expanding apps into the clinical setting, this audio CD/Transcript will provide a detailed look at the emerging market for medical device apps.

Listeners will come away with ideas on how to transform their traditional devices into apps, a better understanding of what needs FDA approval and lessons learned from a firm that already has an FDA-approved app on the market.

Get answers to your toughest questions — in just a day.  No travel required.  Gather your colleagues for the best, and most cost effective, training in the industry.

Order the audio CD/Transcript today and discover what’s really necessary to develop an FDA-compliant medical device application.

Your chairperson is Tim Gee, principal and founder of Medical Connectivity Consulting and a principal consultant with Santa Rosa Consulting. Mr. Gee has more than 25 years of experience working with providers and manufacturers on workflow automation through the integration of medical devices with information systems and enabling technologies.

Mr. Gee, along with other top professionals, will teach you:

  1. How to decipher the general parameters of the scope of FDA regulation of mobile medical apps
  2. What the FDA means when it uses the words “health” versus “wellness”
  3. The FDA’s concept of intended use — is clarification needed?
  4. Accessories, accessories, accessories:  What are accessories and which accessories does FDA regulate?
  5. When the FDA regulates decision-support software found in a mobile app
  6. How to address the challenges and barriers to market entry for a medical device manufacturer
  7. Obtaining FDA clearance – identifying and addressing the safety and effectiveness criteria
  8. How to become a strategic supplier – using an app to leverage your company strategy
  9. Where the future of mobile medical apps is moving.  How will the FDA, devicemakers and clinical organizations work together to best serve patients?

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Key people throughout your company will benefit from this audio CD/Transcript of the virtual conference.

The subjective nature of import holds means you may have a different experience at Entry Point A than at Entry Point B, C, or D. If your shipment lands on a day when an inexperienced Customs or FDA person is in charge, it could be a very bad day indeed.

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Meet Your Instructors

Brad Thompson, Member, Epstein Becker & Green; General Counsel, mHealth Regulatory Coalition

Kyle Peterson, Director, Regulatory & Corporate Affairs, Calgary Scientific

Tracy Rausch, Chief Technical Officer, DocBox

Tim Gee, Principal, Medical Connectivity Consulting (Chairperson)

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