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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India’s Ministry of Health and Family Welfare released draft guidance on essential principles for safety and performance of medical devices marketed in India.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Australia’s Therapeutic Goods Administration released new draft guidance spelling out what steps are needed when devicemakers that have been issued conformity assessment certificates in Australia and want to make a change.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
The investigation involves potential false and misleading statements executives made in connection with Avinger’s January 2015 initial public offering. Read More