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The FDA’s Patient Engagement Advisory Committee (PEAC) will hold its inaugural meeting in Gaithersburg, Maryland, October 11-12 to discuss how patients, devicemakers, and the FDA can share information. Read More
As one of its final items before leaving for the summer, the Senate overwhelmingly voted to reauthorize the FDA’s user fee agreements through fiscal 2022, completing over two years of work. Read More
The FDA finalized its list of 1,003 class II medical devices low-risk enough to be exempt from 510(k) requirements, but stressed that all devices, exempt or otherwise, are subject to current device GMPs, packaging and labeling rules, and regulations on intended use. Read More
In a written comment to the agency, the industry group said the rule is likely to confuse device manufacturers because of how it regulates communications on approved and off-label device uses. Read More
India’s Ministry of Health and Family Welfare released draft guidance on essential principles for safety and performance of medical devices marketed in India. Read More