RAPS

FDA clarifies definition of devices vs. counterfeit devices

The US Food and Drug Administration has published draft guidance updating its definition of a device in accordance with the 2021 Safeguarding Therapeutics Act. The document – published 10 November – ...
Medical Device and Diagnostic Industry (MD+DI)

FDA Clarifies When Software & Wellness Products Are Not Medical Devices

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...
RAPS

FDA Begins Consultation on Software Excluded From Definition of Device

The US Food and Drug Administration (FDA) on Tuesday launched a public consultation on the benefits and risks of certain medical software excluded from the definition of a medical device under the 21 ...
JD Supra

Recent FDA Draft Guidance to Industry Offers Insight on “Content of Premarket Submissions for Device Software Functions”

firmware and other means for software-based control of medical devices; stand-alone software applications; software intended to be operated on general-purpose computing platforms; dedicated ...