FDA
The Food and Drug Administration (FDA or the Agency), the US regulation authority in the sphere of healthcare products, has published a guidance document dedicated to the Global Unique Device Identification Database (GUDID) requirements to be applied for certain...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the content of premarket submissions for device software functions. Table of Contents The document is...
FDA
The present article details FDA guidance on software testing, including tests performed by the manufacturer (software developer) regarding potential changes to the software. The basics of software testing are described in the initial article. The Food and Drug...
FDA
The Food And Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the Global Unique Device Identification Database (GUDID). The document highlights the most important...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the content of premarket submissions for device software functions. The...
FDA
The second article is dedicated to the eligibility criteria the authority will use when determining whether the Safety and Performance Based Pathway could be applied concerning a specific medical device subject to review. The Food and Drug Administration (FDA or the...
