Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
What this record is not
Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA) is proposing to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Digital Breast Tomosynthesis System," to identify these devices along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
Abstract as published in the Federal Register.
READ THE FULL DOCUMENT
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.
Create a free account