Atossa Genetics, a developer of breast health products and services, has received a request for additional information from the US Food and Drug Administration (FDA) related to its 510(k) application for the ForeCYTE breast aspirator.
Atossa plans to request an extension to the 30 day time limit by which a response must be provided to the FDA. If the request for an extension is granted, Atossa will have up to 180 days to provide a response to the FDA’s questions.
Atossa does not view the FDA’s request for additional information as unusual or unexpected and will continue to work toward final clearance of the submission.
Atossa Genetics is focused on proprietary products and services related to breast health through the commercialization of medical devices and, through its wholly-owned subsidiary, The National Reference Laboratory for Breast Health, the offering of laboratory services and tests.