Kanteron Systems has formally communicated its position to the USA Food and Drug Administration (FDA) regarding Document FDA-2021-N-0009-0001.

The document is titled Making Permanent Regulatory Flexibilities Provided During the COVID–19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program

Basically Kanteron Systems, joining other voices in the industry, like the Swedish company Sectra, shared with the FDA its experience as supplier of vendor-neutral DICOM digital pathology software for primary diagnosis around the world (in Latin America, Europe and Asia), and applauded the proposal in FDA’s notice RIN 0991-ZA52 supporting the exemption of product codes PSY, QKQ and PZZ from the requirement for premarket notification (510(k)) for the benefit of patients and users in the USA.