FDA Publishes Final Guidance on Mobile Medical Applications

The FDA has finalized a draft guidance originally published in July 2011 regarding mobile medical applications.

This guidance details FDA’s approach to three categories of applications:

  • FDA does not regulate mobile apps that fall outside the Federal Food, Drug, and Cosmetic Act’s definition of a medical device.
  • FDA intends to exercise enforcement discretion over mobile apps that meet the Act’s medical device definition but pose a lower risk to the public.
  • FDA will apply its regulatory oversight to “mobile medical apps,” mobile apps that meet the Act’s medical device definition and are either:
    o   intended to be used as an accessory to a regulated medical device, or
    o   intended to transform a mobile platform into a regulated medical device.

FDA aims to focus its regulatory oversight on apps that could pose a risk to patient safety if the app does not function as intended.  The guidance includes appendices providing examples of mobile apps that fall within the three categories described above. 

The guidance is available online at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf     

Please contact Sterling if you would like to discuss how this guidance impacts your submissions for IRB review.

Sterling to Attend - 2013 DIA Annual Meeting

Visit us at the 2013 DIA Annual Meeting in Boston, MA June 23-27, 2013. If you’d like to schedule a meeting, contact Kathye Richards, Director of Client Services, at 678.501.7806 / This email address is being protected from spambots. You need JavaScript enabled to view it. .

Sterling to Attend - MAGI East Conference

 Visit us at the MAGI East Clinical Research Conference in Boston, MA May 5-8, 2013. If you’d like to schedule a meeting, contact Kathye Richards, Director of Client Services, at 678.501.7806 / This email address is being protected from spambots. You need JavaScript enabled to view it. .

 

Sterling IRB Awarded AAHRPP Reaccreditation

Sterling IRB Awarded AAHRPP Reaccreditation for Five Years

Sterling Institutional Review Board is pleased to announce that it has been awarded reaccreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. ® (AAHRPP) for five years. Sterling achieved initial accreditation in 2010 and is now AAHRPP accredited until 2018.                         

Long regarded as the industry gold standard, AAHRPP accreditation offers assurances – to research participants, researchers, sponsors, government regulators, and the general public – that a human research protection program is focused first and foremost on excellence not only in protecting research participants, but also in the advancement of more efficient and effective research. More information about AAHRPP accreditation is located at www.aahrpp.org.

Ted Green, president and CEO of Sterling Independent Services, Inc. states, “Our collaboration with AAHRPP has helped Sterling IRB build a strong infrastructure for a high quality human research protection program. I am proud that Sterling has earned the longest reaccreditation period possible from AAHRPP. This is evidence of Sterling’s commitment to protecting research participants and providing excellent service to our clients.”                                                 

Sterling to Attend - AAHRPP 2013 Conference

Visit us at the AAHRPP Conference in Miami, Florida, April 3-5, 2013. If you’d like to schedule a meeting, contact Kathye Richards, Director of Client Services, at 678.501.7806 / This email address is being protected from spambots. You need JavaScript enabled to view it. .

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