The letter detailed a 4-item list of issues and put the de novo process for Ablatherm, a computer-controlled high-intensity focused ultrasound device designed to ablate the entire prostate gland, on hold.
The French firm said that the submission would allow the FDA to resume it’s review.
“As anticipated, we were able to provide a complete formal response to the FDA’s requests in an expeditious manner, which has enabled them to resume active review of our direct De Novo petition. A major component of the response was completion of the reprocessing validation tests, which have all passed. We look forward to the ongoing review of our submission, and plan to continue working closely with FDA to move the process forward,” CEO Marc Oczachowski said in a press release.
In the letter the FDA said it wanted the results of Edap’s reprocessing validation tests, more details on Edap’s physician training program and changes to Ablatherm HIFU’s draft labeling and user manual, EDAP said.
Last fall the FDA issued a “not approvable” letter to Edap for the Ablatherm device after an FDA advisory panel recommended against approval. But the FDA said Edap had until the end of this April to amend the PMA application for a narrower indication.