FDA updates on surveillance inspections during COVID-19
The FDA is collaborating with the CDC to develop a process that would govern how and where to return to on-site facility surveillance inspections in accordance with the gating criteria outlined in the White House Guidelines for Opening Up America Again.
Although inspections are critical, they are one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA regulated products. Safety and quality must be part of the daily routine at any regulated facility for their products to be high quality and reliably suitable for the U.S. consumer.
The FDA is confident in their ability to maintain oversight during this pandemic by leveraging all available authorities, alternative tools, and scientific methods to ensure the integrity and availability of safe and quality products for the American people.
For more details, please see the original communication from FDA.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
Table of Contents
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Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
