FDA Cites Korean Manufacturer Over Unapproved Device
In a recent untitled letter to South Korea-based Ycellbio Medical, the US Food and Drug Administration (FDA) warned of potential violations against medical device regulations.FDA’s review of the manufacturer’s website found its Y-PRP system falls under the FD&C Act’s definition of a medical device. For example, the website states the Y-PRP system “facilitates separating and harvesting ‘pure sources of concentrated platelets’ without much skill.”
But the Y-PRP system has not obtained FDA premarket approval nor 510(k) clearance or exemption, according to the letter.
In March 2016, the firm received an FDA letter that review staff did not find its class III system to have demonstrated substantial equivalence to predicate or reclassified devices.
“Nevertheless, your Ycellbio kit appears to be available for purchase worldwide, including to buyers in the United States,” FDA wrote in the 10 July untitled letter. These findings have resulted in the device being misbranded and adulterated under provisions of the FD&C Act.
The firm was also warned against using FDA’s logo on the device’s brochure, which is posted online, as any “unauthorized use of the FDA logo may violate federal law.”
Last August, the firm planned on featuring its Y-PRP system at an international medical device conference in Korea and said it had already received CE Marking, as well as marketing clearance from the Korea FDA and several other foreign regulators.
It was also “planning to work” with FDA for entry in the US market, though the statement indicated a confusion between a 510(k) clearance and a premarket application approval.
FDA
FDA Cites Korean Manufacturer Over Unapproved Device
In a recent untitled letter to South Korea-based Ycellbio Medical, the US Food and Drug Administration (FDA) warned of potential violations against medical device regulations.
FDA’s review of the manufacturer’s website found its Y-PRP system falls under the FD&C Act’s definition of a medical device. For example, the website states the Y-PRP system “facilitates separating and harvesting ‘pure sources of concentrated platelets’ without much skill.”
But the Y-PRP system has not obtained FDA premarket approval nor 510(k) clearance or exemption, according to the letter.
In March 2016, the firm received an FDA letter that review staff did not find its class III system to have demonstrated substantial equivalence to predicate or reclassified devices.
“Nevertheless, your Ycellbio kit appears to be available for purchase worldwide, including to buyers in the United States,” FDA wrote in the 10 July untitled letter. These findings have resulted in the device being misbranded and adulterated under provisions of the FD&C Act.
The firm was also warned against using FDA’s logo on the device’s brochure, which is posted online, as any “unauthorized use of the FDA logo may violate federal law.”
Last August, the firm planned on featuring its Y-PRP system at an international medical device conference in Korea and said it had already received CE Marking, as well as marketing clearance from the Korea FDA and several other foreign regulators.
It was also “planning to work” with FDA for entry in the US market, though the statement indicated a confusion between a 510(k) clearance and a premarket application approval.
FDA