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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of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week.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
Manufacturers of medical devices that contain nanomaterials should use a phased approach to evaluate risk to avoid unnecessary testing, an expert committee of the European Commission recommends. Read More
Before manufacturers complete their risk-management processes, they should perform a risk-benefit analysis for any risks that are unacceptable under Annexes Z in EN ISO 14971: 2012, and for which further risk reduction is possible, according to a draft consensus paper from the EU-based Notified Body Recommendation Group.
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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