The US Food and Drug Administration (FDA) has issued its long-awaited final rule establishing requirements for the de novo classification process. The de novo process allows FDA to establish new product classifications for low- to moderate-risk medical devices that meet existing device classifications, thereby significantly easing the regulatory authorization pathway. Speaking with MedTech Dive, partner Dennis Gucciardo said the medtech industry has been “anxiously awaiting these guidance documents from the agency, especially COVID-19 test developers.” He added that if the global pandemic continues deep into FY 2022, it is possible that these guidances will not be issued as planned and “FDA will continue its enforcement policies and emergency authorizations into FY 2023."