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Medtech companies that make modest improvements to their products will, in most cases, not need to file a new 510(k) with the U.S. Food and Drug Administration, a Feb. 25 report to Congress says. Read More
Devicemakers planning a premarket approval application or product development protocol should take advantage of presubmission meetings with the U.S. Food and Drug Administration to pin down exactly what data the agency expects to support safety and efficacy of a new product. Read More
Citing the growing complexity of medical devices, the U.S. Food and Drug Administration says it will create a devices-only enforcement unit with subspecialists, where necessary, “to carry out effective oversight” of manufacturers. Read More
Devicemakers should take steps now to secure a production account for submitting electronic Medical Device Reports, ahead of an Aug. 14, 2015 deadline for compliance with mandatory eMDRs. Read More
India’s Ministry of Health and Family Welfare has begun publishing data about compensation paid in clinical trial-related deaths, with the first wave of data covering 2010 into 2013. Read More
U.S. Food and Drug Administration Commissioner Margaret Hamburg said her 10-day trip to India succeeded in syncing U.S.-India views on quality of medical products. Read More
It appears highly likely that the European Parliament won’t finalize the proposed medical device and IVD regulations before May elections, a lawyer familiar with the legislation says. Read More
China’s State Council last month approved the Medical Device Regulations (Amendment Bill), framework, paving the way for broad changes in device classification, adverse event reporting and monitoring of quality in device manufacturing. Read More
An FDA action plan on subgroup analysis, currently in the works, could make device trials excessively large and expensive by imposing unnecessary requirements, AdvaMed warns. Read More
Four patients died after switching to a new form of controller for Thoratec’s HeartMate II Left Ventricular Assist System, the company revealed in a Tuesday recall announcement, adding the deaths did not involve a product malfunction. Read More
The current kerfuffle around online direct-to-consumer genetic testing service 23andMe.com came out of “a perfect storm” that led to the widespread marketing of such tests, experts say. Read More