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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India’s Ministry of Health and Family Welfare released draft guidance on essential principles for safety and performance of medical devices marketed in India.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
Employees of national, provincial and local government agencies are not entitled to additional remuneration if they serve on the SAHPRA board. Read More
Australia’s Therapeutic Goods Administration released new draft guidance spelling out what steps are needed when devicemakers that have been issued conformity assessment certificates in Australia and want to make a change. Read More