Regulatory Focus™ > News Articles > 510(k) Filing Strategy Could Become Used More After Successful Launch of Eye Device

510(k) Filing Strategy Could Become Used More After Successful Launch of Eye Device

Posted 08 February 2012 | By Alexander Gaffney, RAC 

The 510(k) approval process used by North Carolina company TearScience could represent a new and imitable strategy for other companies to follow, said TearScience CEO Tim Willis in remarks to Med City News on 7 February.

The company's device, the LipiFlow Thermal Pulsation System, is used to treat dry eye by clearing channels that supply the eye with moisture-retaining oils.

The company applied for 510(k) clearance in two separate filings, and received clearance from the US Food and Drug Administration just seven months after their initial filing.

"If you tried to do both of these filings (at once), especially in this regulatory environment, I doubt we'd get cleared by now," said Willis.

The FDA's 510(k) process is used by companies to prove "substantial equivalence" to existing medical devices in lieu of conducting time consuming and costly clinical trials to prove a device's safety and efficacy.

"In hopes of speeding things along, the company made an initial filing for the part of LipiFlow that treats the patient - the disposable piece that is used on the patient's eye," wrote MedCity News. "After that part received FDA clearance, the company filed its application for what the physician uses including upgraded software and a handheld unit. It's the full unit that TearScience will be marketing in the United States."


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