FDA Regulation

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How do I get FDA Approval for an at-home Hardware Device?

Robert Bent Founder - INVI Energy

December 28th, 2014

I am looking for a consultant to help me navigate the FDA approval process. I am converting a clinical device into hardware for use at-home directly... More

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Why is the FitBit not a Class 2 medical device if diabetics use it to monitor glucose levels?

Ken Steinberg Innovator and Serial Market Disrupter

June 30th, 2016

Here is the first line from FitBit's Facebook page. "Many of our Fitbit community members use the tracker functionality to monitor their blood glucose... More

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FDA Medical Device Question: Can you have it both ways?

Gerry DeSeve President, Climateon

January 20th, 2016

When doing customer research and sharing my wearable tech product concept with people, I'm often asked if it could be used to treat hot flashes. I've... More

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Capital plan to clear FDA with medical device

Vinit Modi Co-Founder Campusly | Mobile Web & User Research Consultant | Strategic Leadership

April 17th, 2014

We have a patented medical device but our capital plan calls for $40K funding for clearing the FDA.Do investors invest in companies that are pre-FDA... More

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Does a software platform need FDA approval?

Richard Pridham Investor, President & CEO at Retina Labs

August 8th, 2016

I am looking for an expert opinion as to whether or not our platform requires FDA approval. Some background: I recently took over a software telehealth... More

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