FDA Issued Final Guidance on Mobile Apps

Today the FDA released a final guidance document outlining the agency's approach to mobile apps.  According to the guidance document, the FDA intends to exercise enforcement discretion for the majority of mobile apps that pose minimal risk to consumer (meaning the FDA will not regulate these apps as medical devices).  These include mobile apps that:

• 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.

Instead, the FDA intends to focus its oversight on mobile medical apps that:

• are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
• ransform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.

For more information: Mobile Medical Applications Final Guidance: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

FDA Finalizes Rule and System to Identify Medical Devices

The Food and Drug Administration (FDA) issued a long-awaited rule today requiring companies to include codes on medical devices that will allow tracking and monitoring of the devices. 

The rule consists of two parts: unique device identifiers (or UDI codes) assigned by device makers to their devices, and a public database (called Global Unique Device Identification Database or GUDID) containing the UDI codes that will be managed by the FDA.

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.

The FDA plans to phase in the UDI rule.  All Class III devices must carry UDI labels within 1 year.  Most Class II devices must comply within 2 years, and any Class I devices not exempt from the rule will have 5 years to comply. 

The new rule is effective 90 days after today's publication in the Federal Register.

• FDA's News Release on the new rule: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369276.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
• Final rule: https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system
• Draft guidance on GUDID: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf