Pyng Medical had pursued FDA approval to market CRIC in the US via 510(k) premarket notification. FDA has determined CRIC to not be substantially equivalent to the predicate device (a legally marketed device in its category) used in the company’s submission and therefore is not eligible to be cleared for commercial distribution via the 510(k) process.

Pyng Medical intends to pursue a different path to FDA clearance and will resubmit CRIC for review after obtaining additional data and field-usage experience on the safety and efficacy of the product.

Pyng said that the CRIC had previously received the CE mark in Europe via the European Medical Device Directive 93/42/EEC, and has also been cleared by Health Canada and the Australian Therapeutic Goods Administration. As a result, CRIC is currently for sale in Europe, Canada, Australia and other countries which accept the major regulatory agency approvals.

CRIC is indicated for use in obtaining a surgical airway for patients where intubation is not an option and the product provides a rapid Cricothyroidotomy solution (including illumination) in a single compact device. Testing performed to date has indicated that CRIC delivers fast and effective airway access via this singular device as opposed to current methods which require several kit components.

Robert Di Silvio, president and CEO of Pyng, said: “Previous clearance for commercial distribution of CRIC in Europe, Canada, Asia and South America will allow Pyng to grow in these international markets, where substantial opportunity exists, while working in parallel on FDA clearance in the US.”