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Manufacturers are all but blocked from using split predicates for 510(k) devices, under a newly finalized U.S. Food and Drug Administration guidance on substantial equivalence determinations. Read More
For the first time, manufacturers submitting 510(k)s would have to show U.S. Food and Drug Administration reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is strengthening its ability to respond to postmarket medical device safety issues by creating a fast-acting committee of expert advisors that can rapidly review safety problems. Read More
Manufacturers of moderate-risk devices with a good record of GMP compliance could see less of government inspectors, under proposed amendments to South Korea’s good manufacturing practice regulations. Read More
With five new medical device regulations set to take effect in China on Oct. 1, industry insiders are worried the short transition period will affect supply of products in the country. Read More
The public can view device incident reports dating back 20 years under the openFDA initiative, which launched in June with some drug data and is now getting underway for devices. Read More
Manufacturers implementing unique device identification may choose a barcode for their Automatic Identification Data Capture technology, or they can use “any other technology that serves the same objectives,” new FDA guidance clarifies. 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 Wednesday. Read More
A former FDA employee plans to press forward with efforts to remove Lasik eye surgery devices from the market following the agency’s denial of his citizen petition seeking the ban. Read More
The FDA has released a three-point action plan aimed at encouraging more diverse patient participation in medical device and drug clinical trials. Read More
The Centers for Medicare & Medicaid Services will launch its Sunshine Act open payments database on schedule next month, but about a third of submitted data won’t be posted, the agency said Aug. 19. Read More
The Internal Revenue Service may soon begin sending reminder notices to devicemakers it suspects of failing to pay the new 2.3 percent medical device excise tax after the agency found revenues from the tax fell more than $250 million short of expectations in the first half of 2013. Read More