August 19, 2011 by MassDevice staff
The FDA released a Final Rule determining eyelid thermal pulsation systems like TearScience’s LipiFlow are Class II devices, allowing them to bypass stringent premarket approval standards.
The FDA released a final rule declaring thermal pulsation systems Class II devices, allowing them to bypass the more stringent premarket approval required for Class III devices, in response to a petition from TearScience Inc.Morrisville, N.C.-based TearScience had petitioned the watchdog agency to classify its LipiFlow eyelid thermal pulsation device, used in treatment of evaporative dry eye, as a Class II device.
The LipiFlow device assesses tear film and gland function and apply energy to a patient’s eyelid in a 12-minute office treatment.
LipiFlow was automatically relegated to the more stringent Class III category because it was not found substantially equivalent to any “preamendments devices,” those in the market prior to the Medical Device Amendments act of 1976 which are commonly used as predicate devices for 510(k) applications.
The FDA reviewed LipiFlow’s application and petition for reclassification, determining that the eyelid thermal pulsations devices could be downgraded to the more lenient Class II category, meaning they don’t need to undergo clinical trials in order to make it to market.
TearScience won FDA clearance for LipiFlow in July.