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Devicemakers should ensure their devices are designed and manufactured such that the risks associated with “reasonably foreseeable environmental conditions” are removed or minimized. Read More
The committee met in 2019 to discuss how healthcare providers and the agency should communicate medical device cybersecurity risks to patients and the public. Read More
The FDA has released a new draft guidance that lays out a step-by-step process for applying data from a previously approved delivery system, a practice commonly known as bridging, to an application for a combination product. Read More
Health Canada has finalized guidance on software as a medical device (SaMD) that clarifies how it fits into the agency’s regulatory framework and how devicemakers can comply. Read More
Cocaine and cocaine metabolite test systems are exempt from premarket notification procedures if they are intended for employment and insurance testing and say that on the labeling. Read More
The agency said electronic format includes eCopies, eSubmissions, and submissions created and submitted on CD, DVD or flash drive and mailed to the FDA. Read More