USA – FDA final guidance adds more details to Q-Sub program
The US Food and Drug Administration has finalized an updated guidance on its Q-Submissions program that allows medtech companies to engage with regulators early...
USA – Medical Devices Regulatory Update / FDIS 10993-1 Released: Requirements and General Principles...
The Final Draft International Standard (FDIS) of ISO 10993-1 has been released launching the 8-week ballot period and signaling important changes ahead for medical...
USA – FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease
The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s...
USA – FDA reissues sex-specific data guidance after sanitizing anything considered DEI-related
As part of President Donald Trump’s directive to eliminate anything construed as related to diversity, equity and inclusion (DEI), the US Food and Drug...
Canada – Health Canada Continues to Actively Monitor Supply of Medical Devices
On March 2, 2022, amendments to the legislation in Canada, Medical Devices Regulations (SOR/98-282, Part 1, Sections 62.21 to 62.26) came into force. These provisions...
Canada – Draft guidance on managing applications for medical device ...
Medical devices are classified into 1 of 4 classes, where Class I represents the lowest risk and Class IV represents the highest risk. Under...
USA – Drug, device makers scramble for tariff exemptions, warn of supply disruptions
Drug and device manufacturers are raising concerns about President Donald Trump’s tariffs on imports from China, Mexico, and Canada, warning that they could worsen...
USA – FDA finalizes guidance on reporting medical device shortages
The US Food and Drug Administration (FDA) issued finalized guidance on its requirements for notifying the agency of potential medical device shortages during or...
USA – FDA issues much-anticipated guidance on pulse oximeters
The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can be...
USA – FDA issues draft guidance on developing and managing AI-enabled devices
The US Food and Drug Administration (FDA) on Monday published a much-anticipated guidance on developing and managing medical devices with artificial intelligence (AI). The...
