News

Regulatory Medtech groups want more time to implement FDA’s QMSR rule While the medtech industry is overwhelmingly supportive of the long-awaited proposed Quality Management System Regulation [...]

Regulatory  FDA expands eSTAR filing to de novo devices, IVDs US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to [...]

Regulatory FDA issues draft guidance for device software in premarket submissions The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about [...]

Regulatory FDA nixes GUDID submission requirements for class I consumer healthcare devices Manufacturers of class I medical devices considered to be consumer healthcare products will get a [...]

Regulatory FDA issues draft guidance on electronic 510(k) submissions The US Food and Drug Administration (FDA) issued a draft guidance to assist sponsors in using an electronic template for [...]

Regulatory FDA seeks more power for medical device cybersecurity mandates FDA is seeking “additional legislative authorities” meant to bolster medical device cybersecurity amid [...]