RegDesk Regulatory Roundup

Dec 2, 2022

FDA Guidance on Diagnostic Clinical Performance Studies: Key Points

The new article addresses the aspects related to the design considerations for diagnostic clinical performance studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...

FDA Guidance on Medical Device Patient Labeling: Warnings and Precautions

Aug 31, 2022

FDA

FDA Guidance on Medical Device Patient Labeling: Warnings and Precautions

The new article addresses the aspects related to warnings and precautions to be included in medical device patient labeling. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...

FDA Guidance on Patient Labeling: Appearance of Text and Graphics

Aug 24, 2022

FDA

FDA Guidance on Patient Labeling: Appearance of Text and Graphics

The article provides additional details regarding the medical device patient labeling. In particular, it describes the requirements regarding the appearance of text and graphics. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...

FDA Guidance on Medical Device Patient Labeling: Overview

Aug 7, 2022

FDA

FDA Guidance on Medical Device Patient Labeling: Overview

The article provides an overview of the applicable regulatory requirements in the sphere of labeling for medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...

FDA Guidance on PMA Decision-Making Process: 30-Day Supplement

Aug 7, 2022

FDA

FDA Guidance on PMA Decision-Making Process: 30-Day Supplement

The new article describes in detail one of the regulatory pathways to be used in case of changes to an already marketed medical device – a 30-day supplement. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...