Avita Medical submitted its PMA for Recell Go on June 30, and...

Avita Medical submitted its PMA for Recell Go on June 30, and that set up the typical 180-day review cycle for the product. It's important to note the FDA is asking for more information, and its letter is not the same as a critical response letter, which can be the death knell for a prospective product. The Recell Go is more automated version of an already cleared device, the Recell.The FDA's letter slows down the clearance process. Initially, Avita had expected an approval from the FDA by Dec. 27. The FDA letter puts the application on hold for four to six months months until Avita can answer the FDA's concerns regarding the device. Once the company's response is complete, the application will begin anew the 180-day window, which could still mean a new product launch between May 1 and July 1.

Avita is in a relatively strong position to be able to wait.