North America Archives

Aug 8, 2022

FDA Guidance on PMA Supplement Decision-Making Process: Changes to Manufacturing Site and Periodic Reports

The new article describes in detail the regulatory approach to be applied in case of changes to the manufacturing site, and also provides additional clarifications regarding the reporting requirements. Table of Contents The Food and Drug Administration (FDA or the...

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...

FDA Guidance on PMA Decision-Making Process: Special PMA Supplement

Aug 7, 2022

FDA

FDA Guidance on PMA Decision-Making Process: Special PMA Supplement

The article describes in detail another type of submission – a special supplement. In particular, the article provides an overview of the applicable regulatory framework and also explains the examples illustrating the situations when a special supplement will be...

FDA Guidance on Home Use Devices: Postmarket Considerations

Aug 7, 2022

FDA

FDA Guidance on Home Use Devices: Postmarket Considerations

The new article provides a detailed overview of the regulatory requirements related to postmarket considerations for home-use products. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...

FDA Guidance on PMA Supplement Decision-Making Process: Real-Time Supplement

Aug 2, 2022

FDA

FDA Guidance on PMA Supplement Decision-Making Process: Real-Time Supplement

The new article describes in detail another type of submission – a real-time supplement. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...

RegDesk Regulatory Roundup

FDA Guidance on PMA Supplement Decision-Making Process: Changes to Manufacturing Site and Periodic Reports

FDA Guidance on Medical Device Patient Labeling: Overview

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

FDA Guidance on PMA Decision-Making Process: Special PMA Supplement

FDA Guidance on Home Use Devices: Postmarket Considerations

FDA Guidance on PMA Supplement Decision-Making Process: Real-Time Supplement

Categories

Categories

Tags