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Most comments on the FDA’s draft guidance for reclassifying surgical staplers supported the move to reclassify devices from Class I to Class II but some cautioned that the rule could adversely affect access to the products. Read More
With only nine months to go before the EU’s Medical Device Regulation hits its May 26 application date, the U.S. is pressing the EU to delay implementation for another three years. Read More
Combination products marketed under a device application have up to 30 calendar days to submit an adverse event report for “serious” and “unexpected” events. Read More
France’s National Medicines Agency has established a pilot project to prepare for implementation of the new EU Medical Device Regulation and In Vitro Diagnostics Regulation. Read More
TGA said that manufacturers are responsible for assessing and managing the cyber security risks of their devices before they reach the market. Read More