FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What is the purpose of the State of the Art section? Is it simply background, current setting, alternative therapies? Or are we intended to demonstrate our device is state of the art? What happens if it isn’t? I have heard repeatedly there will be “no more grandfathering” for established devices with a long market history. What does that mean under the new MDR? Will we need to sponsor clinical studies or proactively develop new clinical data? Do the Notified Bodies have a clear understanding of requirements under the MDR or are they waiting on regulatory agencies’ interpretation? Are we all grasping at straws as we figure out what the expectations will be? 1.68K viewsFDA 0 Votes 1 Ans MDSAP vs MDR—will Notified Bodies have two separate audits that may be performed at the same time? 1.57K viewsFDA 0 Votes 1 Ans Is A Pre-submission A Good Idea Or A Bad Idea? 1.55K viewsFDA 0 Votes 1 Ans What feedback have you received from people who volunteered to participate in a clinical trial? 1.68K viewsFDA 0 Votes 1 Ans What would you say to a potential volunteer that is afraid they won’t receive the same level of care in a clinical trial as what they receive under their doctor’s care? 1.51K viewsFDA 0 Votes 1 Ans What are the most frustrating things about working in the clinical trials recruitment and retention area? 1.63K viewsFDA 0 Votes 1 Ans What do you think can be done to improve interactions between principal investigators and study teams and potential clinical trial participants? 1.35K viewsFDA 0 Votes 1 Ans What steps is ICAN taking to move the clinical trials process forward? 1.56K viewsFDA 0 Votes 1 Ans Does the CMO have a strong quality management system? 1.55K viewsFDA 0 Votes 1 Ans Does the CMO have supply chain expertise 1.63K viewsFDA 0 Votes 1 Ans Does the CMO have sufficient capacity in production and engineering? 1.66K viewsFDA 0 Votes 1 Ans How will the CMO handle your production plan? 1.50K viewsFDA 0 Votes 1 Ans Can the CMO provide staffing charts? 1.63K viewsFDA 0 Votes 1 Ans Does the CMO foster continuous improvement? 1.61K viewsFDA 0 Votes 1 Ans Is the CMO’s work culture compatible with yours? 1.39K viewsFDA 0 Votes 1 Ans Is there potential for automated processes? 1.35K viewsFDA 0 Votes 1 Ans Is the CMO financially stable? 1.46K viewsFDA 0 Votes 1 Ans Are the CMO’s facilities a good fit for your product? 1.52K viewsFDA 0 Votes 1 Ans Who is the contracting entity? 1.74K viewsFDA 0 Votes 1 Ans The transition period doesn’t end until May 2020. Why start now? 1.68K viewsFDA « Previous 1 2 … 66 67 68 69 70 … 75 76 Next » Question and answer is powered by anspress.net
