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The FDA issued two new guidances for sponsors of products designed to treat hay fever as well as other cold-like symptoms that aren’t caused by allergies — and said it considers the delivery system for a topical drug as part of its review, so the whole product is evaluated as a hybrid drug/device. Read More
The past year has seen a flurry of activity around China’s medical device regulations and much of the reforms have been focused on encouraging innovation while at the same time beefing up post-market enforcement. But for the reforms to be successful, the regulators should consult more with industry, according to attorneys at Ropes & Gray. Read More
As medical instruments have become more complex, “reprocessing has become more complicated and time consuming,” said Sharon Silas, acting director of the GAO’s health care team. Read More
Citing post-market safety concerns about the delivery accuracy of infusion pumps, Health Canada is updating the evidence requirements to demonstrate the accuracy of these devices through performance testing for new and amended license applications. Read More
The FDA extended the compliance date for Global Unique Identification Database (GUDID) submission requirements for combination products, giving devicemakers another year to comply. Read More
The FDA issued a list of medical device accessories that it believes are safe and effective enough to be categorized as Class I and requested public feedback on the proposed list. Read More