Medical Devices

Overview of Medical Device Data Systems, General Wellness Devices, and Medical Device Accessories - February 24, 2015


Summary: On February 6, 2015, the FDA posted final guidance documents on medical device data systems (MDDS) and mobile medical apps (MMA).  We also recently posted draft guidance on our general wellness policy for low risk devices and medical device accessories. Through these actions, we continue to clarify which medical devices are of such low risk that we will no longer focus our regulatory oversight on them or we will regulate them under a lower risk classification, narrowly tailoring our approach to the level of risk to which patients or consumers are exposed.

On February 24, 2015, the FDA will hold a webinar for industry and other interested stakeholders. The webinar is intended to give an overview of FDA’s approach to regulating MDDS and to help stakeholders understand the draft policies described in the general wellness and medical device accessories guidance documents and solicit comments.  Following a brief presentation, the FDA will respond to questions regarding all four 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.

**Note: The FDA is unable to provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.

Target Audience: Industry and other interested stakeholders

Attention: In an attempt to ensure that every participant is able to log in to the webinar, we’ve added an additional link. If you receive an error message while using the original link, please use the following link to obtain access to the live presentation:

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