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In a final guidance released on Friday, the FDA said it will enforce standard date formatting and Unique Device Identification (UDI) labeling requirements for certain class I and unclassified devices starting on Dec. 8. Read More
The Department of Justice (DOJ) has launched a nationwide law enforcement action against fraudulent billing for cardiovascular and cancer genetic tests and medical devices. Read More
The FDA has granted Breakthrough Device designation to Roche’s Elecsys Amyloid Plasma Panel, a minimally invasive test for early diagnosis of Alzheimer’s through blood biomarkers, which could become the first FDA-approved test for this disease. Read More
The FDA’s draft guidance on cybersecurity for devices is a good start but needs some clarification, according to a working group of the International Organization for Standardization (ISO) and a variety of devicemakers. Read More
In the absence of a fully functional Eudamed database, the EU’s Medical Device Coordination Group (MDCG) says diagnostics companies should continue to follow individual national regulations for regulatory filings and other actions until the portal comes fully online in two years. Read More
To meet a requirement of the 21st Century Cures Act, the FDA is seeking comments for a report on the patient safety and best practices impact of nondevice software functions. Read More
The FDA’s review of proposed instructions for use (IFU) for a new drug, biologic or combination product will focus on accuracy and consistency with the agency-approved prescribing information, according to a final labeling guidance issued yesterday. Read More