Medical devices have entered a legal gray area--where startups are using crowdfunding websites to pay for the development of their tools before the U.S. Food & Drug Administration has cleared them for use.
Despite products being potentially years away from being reviewed by the FDA, entrepreneurs are gaining customers through sites like Indiegogo, with no guarantee their products will be shipped out at all, according to an article in the Boston Globe.
Stephen Marsh is one of those entrepreneurs. He tells the Globe that while he is looking to obtain clearance from the FDA for a disposable medical device to treat sleep apnea, he needs the money to fund the project now. To that end, Marsh has turned to Indiegogo to engage with customers and get funding for his device.
This kind of practice is in a legal gray area, one that federal regulators are not sure how to address, according to the article.
"There are always risks and benefits to a product--that's what the FDA usually assesses," Paul Brown, government relations manager for the National Center for Health Research, tells the Globe. "If the FDA is not given a chance to even assess it, then all that risk falls onto the consumer or the patient."
However, the FDA says it won't examine low-risk general wellness products to determine whether they are devices within the meaning of the Federal Food, Drug, and Cosmetic Act, according to draft guidance documents published by the agency in January.
In addition, the federal agency created a voluntary program, the Expedited Access Program, to speed medical devices to patients who have life-threatening conditions while not compromising FDA's safety standards, FierceHealthIT previously reported.
To learn more:
- here's the Globe article