WHEN: Thursday, February 26, 2015
TIME: 12:00pm – 1:30pm EST
To register for this webinar, please click here.
Please join us for a complimentary webinar addressing wireless health regulatory issues. This session will discuss recent trends in health technology regulation; including Food and Drug Administration (FDA) developments, Federal Communications Commission (FCC) requirements, wireless technology and communication issues, mobile applications, decision support and other Health IT challenges, and privacy and cyber security considerations.
This session is relevant to tech companies, communications companies, entrepreneurs, and developers that are entering the wireless health technologies space or considering acquiring mobile health assets.
Topics … Continue Reading
FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.
The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are “low risk” and are intended to:
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- Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
- Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy lifestyle may reduce the risk
At the January 8-9, 2015 FDA public meeting on the agency’s proposal to regulate a portion of lab developed tests (LDTs), there was much debate regarding whether FDA has jurisdiction over IVDs made at clinical laboratories. Not coincidentally, on January 7, the day before the meeting, the American Clinical Laboratory Association released a white paper developed for the Association by a couple of prominent constitutional law scholars. The paper outlined the arguments at a high level against FDA jurisdiction over lab developed tests generally. But with all due respect to the authors as well as the speakers at the FDA … Continue Reading