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Crowdfunding creates unique challenges for medical device makers

There is a lot of grey area when it comes to devices that can be bought before getting FDA approval.

Crowdfunding has become a popular way for entrepreneurs to raise money for their ideas and products.

But, when those products are medical devices, it can get complicated, because many times they are selling a product that has not gotten FDA approval yet, and could be months, or years, away from it.

Stat, a national publication launching this fall from the Boston Globe Media Partners, recently took a look at the issue, and found it is not as black and white as other types of crowdfunding campaigns.

Some issues include making medical claims that are not supported by studies or the FDA, and delayed delivery of the product.

When it comes to people essentially buying a medical device that has not been approved by the FDA, the agency told the news outlet that companies must still follow their marketing and advertising rules, no matter how they raise funds.

Those who use the sites to raise money are aware of the issues.

“We need to toe the line between saying what’s accurate and true ... and getting this out there as quickly as possible,” Rosalind Picard, an MIT professor and Empatica’s chief scientist told Stat. “So you’ll see us use all this careful language.”

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