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Devicemakers are urging the incoming president of the European Commission to clarify once and for all whether medical technologies will continue to be overseen by the directorate for health or move to industry, as previously proposed. Read More
The International Medical Device Regulators Forum is seeking feedback on a proposed plan to share adverse event reports among national regulatory authorities.
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Given past experience with metal-on-metal joint replacements, the introduction of new prostheses should be both gradual and backed up by new and stronger preclinical and clinical studies, a panel of scientific experts in the EU says. Read More
The U.S. Food and Drug Administration last month unveiled a broad plan that will change the way it inspects devicemakers, handles recalls, issues and reviews enforcement decisions and screens imports, with companies likely to start feeling the impact by the end of 2015. Read More
The Australia government plans to fast-track approvals of promising new medical technologies and conduct joint reviews with trusted foreign regulators as part of a broad effort to streamline the country’s device approval process. Read More
Three months after the EU’s RoHS 2 deadline, Stryker has reviewed more than 600 products and dealt with “significant” costs to comply with the regulations. Fortunately, the company has had a relatively easy time finding alternative components when necessary. Read More
Devicemakers need to be vigilant against possible embedded medical device software vulnerabilities as the FDA continues to develop a formal cybersecurity strategy, a security expert warns. Read More
Devicemakers are urging the incoming president of the European Commission to clarify once and for all whether medical technologies will continue to be overseen by the directorate for health or move to industry, as previously proposed. Read More
Recent FDA guidance on distributing scientific publications that cover off-label uses is out of touch with today’s data-driven economy and should be modified to embrace digital communication platforms, a Washington, D.C. think tank says. Read More
CDRH is steadily chipping away at PMA and 510(k) review times, but the improvements are not enough to make the US competitive with the EU, which sets a far lower bar for approving new devices. Read More
As EU notified bodies begin conducting the unannounced audits required by the European Commission, devicemakers need to make sure they have at least two employees who are prepared to handle an audit. Read More