FDAnews Announces — New Management Report — Mobile Medical Apps: Keeping Up with the FDA’s Evolving Requirements

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Just because an app is running on an unregulated phone or tablet doesn’t mean that the app itself isn’t a medical device in the FDA's eyes. The Mobile Medical Apps management report explains what the FDA means by enforcement discretion and how it considers an app’s intended use in category assignment.

Mobile Medical Apps:
Keeping Up with the FDA’s Evolving Requirements
**An FDAnews Management Report**
http://www.fdanews.com/mobileappsmr

Just because an app is running on an unregulated phone or tablet doesn’t mean that the app itself isn’t a medical device in the FDA's eyes.

Where does the agency draw the line between unregulated products and those it must approve?

The final guidance for Mobile Medical Applications helps clarify the FDA’s position on regulating mobile apps, but leaves several areas open to interpretation.

Manufacturers need to know:

  • How the FDA categorizes mobile apps and decides how — or whether — to regulate them as medical devices.
  • How the FDA evaluates an app’s “intended use.”
  • How to interpret the FDA’s promise of “enforcement discretion” for certain types of apps.
  • Who can be considered a mobile medical app developer and what regulations affect them.

This management report interprets the FDA’s evolving stance on mobile apps and explains how the FDA sorts mobile apps into three categories:

1. Administrative health information technology (e.g, billing, claims processing, general communication and scheduling): This is not a medical device and not regulated by the agency.

2. Health management information technology (e.g., medication management, data capture, electronic access to clinical results, provider order entry): This is under FDA jurisdiction but generally so low risk that the agency can exercise enforcement discretion and not apply regulations.

3. Medical device health information technology (e.g., computer-aided detection and diagnosis, robotic surgical planning, remote display of bedside alarms, radiation treatment planning): This is actively regulated under Class I, Class II and Class III medical device rules.

Mobile Medical Apps explains what the FDA means by enforcement discretion and how it considers an app’s intended use in category assignment.

Who Will Benefit:

  • Compliance officers
  • Engineering and design controls teams
  • Executive management
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff

Management Report Details:
Mobile Medical Apps:
Keeping Up with the FDA’s Evolving Requirements
Price: $397
http://www.fdanews.com/mobileappsmr

Easy Ways to Register:
Online: http://www.fdanews.com/mobileappsmr            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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