FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity

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FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity:

"In this final guidance, FDA has chosen to use two factors to distinguish between mobile medical apps that are low risk that they do not intend to regulate, and higher risk apps that will be regulated. FDA will regulate those mobile medical apps intended:

• to be used as an accessory to a regulated medical device; or
• to transform a mobile platform into a regulated medical device."

You might also be interested in:
Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB)

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UDI System: The Final Regulation - Free FDA CDRH Video

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FDA | CDRH Learn | Unique Device Identification (UDI) System

"Unique Device Identification (UDI) System"

This is a collection of many presentations. Each of the presentations includes:

• the presentation
• printable slides, and
• a transcript

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Unique Device Identification (UDI) System - FDA Final Rule

Press Announcements > FDA finalizes new system to identify medical devices:

" . . . the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.

The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule."

Follow this link to view the Unique Device Identification System - Final Rule (PDF)

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Recommendations of FDASIA Health IT Workgroup Accepted - FDA Law Blog

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FDA Law Blog: Recommendations of FDASIA Health IT Workgroup Accepted:

"The Food and Drug Administration Safety and Innovation Act (“FDASIA”), signed into law in July 2012, requires the Secretary of Health and Human Services (“HHS”) to "post a report - within 18 months (or by January 2014) - that contains a proposed strategy and recommendations on a risk-based regulatory framework pertaining to health IT, including mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication."  FDASIA Section 618."

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ICH Increases Transparency - Publishes Its New Procedures Manual

ICH Looks to Increase Transparency of its Activities, Processes with New Procedures Manual:

"The International Conference on Harmonisation (ICH), a pharmaceutical regulatory harmonization body consisting of regulators from the US, EU and Japan, is publishing new documents intended to explain in full detail exactly what goes on within its regulatory black box."

For your reference:
ICH Procedures (PDF)

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