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With 12 recalls in less than 36 months, Johnson & Johnson tops the list of the five medical devicemakers with the most Class I recalls between 2012 and the present, according to FDA data. Read More
Manufacturers of nucleic acid amplification test reagents for dengue virus should take a variety of steps, such as optimizing reagents and test procedures for recommended instruments, to prevent false negative or positive results, an FDA Class II special controls guidance recommends. Read More
The International Medical Device Regulators Forum’s single-audit pilot program is running on schedule, an FDA official working closely with the program tells D&DL. Read More
An Australian appeals court has supported Myriad Genetics’ ability to patent genes associated with breast-cancer risk, diverging from last year’s U.S. Supreme Court ruling, which declared the patents invalid. Read More
CDRH is readying its review staff to deal with the additional workload of laboratory-assisted tests, according to a center official who says talks are underway with third-party reviewers to help out. Read More