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Medical device maker Cur adds disclaimers to crowdfunding site after questions about FDA rules

Medical device maker Cur adds disclaimers to crowdfunding site after questions about FDA rules


Marketing language changed after a report by The Verge

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Earlier today, The Verge published a report about Cur, a company that launched a $50,000 crowdfunding campaign yesterday for a medical product — also called "Cur" — that has yet to gain FDA clearance. The story outlined the risks that Cur was running by going against FDA regulations that prohibit advertising and selling a product directly to consumers prior to obtaining FDA clearance. The story also outlined the difficulties that officials may face when trying to regulate campaigns that provide a "reward" in return for a "donation" from "investors" — instead of selling a product to consumers.

You can no longer "get cur now."

Cur's product is a transcutaneous electrical nerve stimulation machine — or a TENS machine — that is meant to alleviate pain. These devices require FDA clearance, but Cur has yet to file for it. Following the report's publication, the company reached out to us to let us know that they had changed their website. Sentences like "50 percent off for 30 days" and "get cur now" now read "support our fundraising campaign" and "invest in Cur," respectively.

Credit: Cur

The new website also features some information about the FDA clearance process. "Early backers have the perk of receiving a device after Cur receives FDA 510(k) clearance," the website now reads. "Devices will not be shipped before the FDA has thoroughly reviewed and cleared the 510(k) Premarket Notification." In addition, the company's founder, Shaun Rahimi issued a statement in response to the report:

Our crowdfunding campaign was designed to support the continuing development operations and 510(k) Premarket Notification submission of Cur. While we thought we were clear, The Verge article enlightened us that our website needed further clarification. Our crowdfunding campaign will remain the same and we are updating our website to reflect that early investors who support us will have the opportunity to receive a Cur perk only after we receive 510(k) clearance from FDA. We have complete confidence that we'll receive FDA clearance based on similar predicate products in the market.

Crowdfunding campaigns raise complicated questions for the FDA, and it’s unclear how the agency will treat solicitations for funding that look a lot like marketing. The Verge reached out to the FDA about Cur's website update. The agency declined to comment.