![FDA Draft Guidance on Delaying an Inspection: Reasonable and Unreasonable Delays](https://www.regdesk.co/wp-content/uploads/2023/01/pexels-karolina-grabowska-4021811-1-1080x675.jpg)
Jan 27, 2023
FDA
The new article addresses the aspects related to different grounds for delays occurring before and during an inspection. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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![FDA Draft Guidance on VMSR Program: Supplemental Reports and Summary Reporting](https://www.regdesk.co/wp-content/uploads/2023/01/pexels-karolina-grabowska-4021775-1080x675.jpg)
Jan 27, 2023
FDA
The new article addresses the aspects related to supplemental reports medical device manufacturers should submit and also provides an overview of the summary reporting instructions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
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![FDA Draft Guidance on Inspection Delays: Overview](https://www.regdesk.co/wp-content/uploads/2023/01/pexels-tima-miroshnichenko-5407217-1080x675.jpg)
Jan 27, 2023
FDA
The article provides an overview of the factors resulting in delaying or refusing an inspection. 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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance...
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![FDA Draft Guidance on Human Factors Information: Risk-Based Approach](https://www.regdesk.co/wp-content/uploads/2023/01/pexels-daniel-frank-287237-scaled-e1673617470828-1080x675.jpg)
Jan 27, 2023
FDA
The new article addresses the aspects related to the risk-based approach to human factors engineering information in marketing submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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![FDA Draft Guidance on VMSR Program: Principles and Eligibility Determination](https://www.regdesk.co/wp-content/uploads/2023/01/pexels-tima-miroshnichenko-5452222-1080x675.jpg)
Jan 16, 2023
FDA
The new article addresses the aspects related to the principles to be followed with respect to voluntary reporting, and also describes the approach the authority applies when determining the eligibility criteria to be considered. Table of Contents The Food and Drug...
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