This Article will argue that medical device companies should be able to utilize crowdfunding to raise the necessary capital to develop a product. However, because of the risks medical devices pose, any solution that allows medical device companies to employ crowdfunding should ensure the continuing commitment to consumer safety that is at the core of FDA regulation. This Article uses the Scanadu Scout as an example and a staring point for evaluating the use of crowdfunding in the medical device industry. This Article explains how and why Scanadu broke the law when it moved the Scout, an “adulterated or misbranded” medical device, through interstate commerce in violation of 21 U.S.C. § 331(a). This Note goes on to explain what this means for other medical device companies looking to copy Scanadu’s strategy.
First Place in the 2014 Food & Drug Law Institute’s H. Thomas Austern Memorial Writing Competition (Long Papers)
70 Food and Drug Law Journal 209-235 (2015)
Smith, Colleen, "Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu’s “Scout”" (2015). Student Award Winning Papers. 9.