Wednesday, September 25, 2013

FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity

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:
FDA's Press Release - FDA issues final guidance on mobile medical apps
Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB)

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Friday, September 20, 2013

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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Thursday, September 12, 2013

Recommendations of FDASIA Health IT Workgroup Accepted - FDA Law Blog

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."

Follow this link to a collection of the HIT Policy Committee's documents, including the draft recommendation.

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Thursday, September 5, 2013