viernes, 6 de febrero de 2015

FDA Issues Final Guidances on Medical Device Data Systems and Mobile Medical Applications

Today the FDA posted a final guidance document on medical device data systems (MDDS).  This guidance confirms our intention to not enforce regulations for technologies that receive, transmit, store, or display data from medical devices.  We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data. We also updated the Mobile Medical Apps guidance to be consistent with the MDDS final guidance.

We will discuss these guidance documents, along with two draft guidances released last month on low risk products intended for 
general wellness and medical device accessories, at a webinar scheduled for February 24, 2015.  The webinar is intended to help manufacturers and other interested stakeholders understand the policies described in these guidance documents.
 Following a brief presentation, the FDA will respond to manufacturer’s questions regarding these guidance documents.

Webinar Details:

Registration is not necessary

Date: February 24, 2015
Time: 2:00 – 3:30 PM, Eastern Time (please connect by 1:45 PM)

To hear the presentation and ask questions:
Dial: 800-779-8169; passcode: 5038387 | International: 1-210-234-8003; passcode: 5038387

To view the slide presentation during the webinar:

Following the webinar, a transcript, recording and slides will be available at: The slide presentation will be available at this site on the morning of the webinar.
Please note that the FDA is unable to provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.
If you have any questions regarding these guidance documents, please contact CDRH’s Division of Industry and Consumer Education (DICE) at, 1-800-638-2041, or 301-796-7100.
If you have any questions regarding the webinar, please contact CDRH Learn.

Food and Drug Administration
Center for Devices and Radiological Health

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