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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
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
The FDA plans to implement unique device identification requirements over several years, “and we fully expect and intend to be flexible during that time,” an agency source says. Read More
The D.C. federal court on Tuesday again blasted the FDA for acting arbitrarily in deciding whether a combination product should be regulated as a device or a drug. Read More
The FDA is pushing ahead with a proposal to regulate laboratory-developed tests, with CDRH chief Jeffrey Shuren showing no signs of backing down despite grilling from congressional skeptics during a Tuesday hearing. Read More
The Brazilian government is proposing major reforms to its public-private Product Development Partnership program, doubling the allowable length of PDP agreements from five to 10 years and establishing a committee to approve the projects. Read More
The device industry is asking the FDA not to impose controls, including quality system regulations, on manufacturers of low-risk health information management software that doesn’t serve a clinical function. Read More
Regulatory challenges in interpreting data from multiregional clinical trials have prompted the International Conference on Harmonisation to prepare a guideline on trial planning and design according to a recent concept paper. Read More
Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current policy. Read More
Sponsors of device clinical trials should carefully examine the demographic distribution of study participants at various points during the study, the FDA says in final guidance published Aug. 20. Read More