SETTLEMENT TRIGGERS CONFUSION OVER 510(K) OWNERSHIP, WARNING LETTER
The FDA warned an Oregon manufacturer to prove ownership of 510(k) clearance numbers or submit new premarket notifications for its dental polymers.
In a May 11 warning letter that was posted May 23, the agency claimed that Talon Acrylics manufactured the Revere and Talon thermoplastic acrylic elastomers under premarket clearance issued to another company, Comfort Acrylics.
Elastomers are rubberlike, temperature-resistant polymers used in the construction of devices such as balloon catheters, feeding tubes and infusion sleeves as well as a variety of seals, stoppers, valves and clips.
Talon Acrylics, the agency said, did not have documentation proving that ownership of the 510(k) clearance numbers had been transferred from Comfort. It was therefore the company's responsibility to establish compliance, "either by obtaining documentation or by making appropriate premarket submissions," the FDA wrote.
Sherman Watson, president of Talon Acrylics, explained that the 510(k) clearance numbers were a bone of contention between his company and Comfort, now operated by Watson's former business partner, Richard Moore.
According to Watson, he and Moore founded Comfort Acrylics in 1990 and received premarket clearance for the Talon elastomer during that partnership. When the partnership dissolved in 1997, Watson said he received the clearance numbers as part of a court settlement, although he admitted that the language of the settlement was vague. "It was an oversight not to mention '510(k)' in the settlement," he said. ()a href="http://www.fdanews.com/ddl/33_22/" target=_blank>