US: FDA guidance on CDRH Appeals Processes

2023-03-29T14:04:09+00:00March 3rd, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: , , , , , , , , |

The FDA published a guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes. The document describes the processes available to external stakeholders to request additional review of CDRH employees’ decisions or actions. It is intended only to [...]

US: CDRH plans full launch of ASCA pilot program in 2021

2023-04-21T10:48:30+00:00January 29th, 2021|Categories: Regulatory, USA|Tags: , , , , |

The US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) annouced the full launch of a pilot conformity assessment program in 2021. Contact Meditrial to know about our strategic assessments of regulatory requirements to address business [...]

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