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? 1.80K viewsFDA 0 Votes 1 Ans MDSAP vs MDR—will Notified Bodies have two separate audits that may be performed at the same time? 1.69K viewsFDA 0 Votes 1 Ans Is A Pre-submission A Good Idea Or A Bad Idea? 1.65K viewsFDA 0 Votes 1 Ans What feedback have you received from people who volunteered to participate in a clinical trial? 1.80K 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? 1.69K viewsFDA 0 Votes 1 Ans What are the most frustrating things about working in the clinical trials recruitment and retention area? 1.73K 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? 1.48K viewsFDA 0 Votes 1 Ans What steps is ICAN taking to move the clinical trials process forward? 1.74K viewsFDA 0 Votes 1 Ans Does the CMO have a strong quality management system? 1.69K viewsFDA 0 Votes 1 Ans Does the CMO have supply chain expertise 1.75K viewsFDA 0 Votes 1 Ans Does the CMO have sufficient capacity in production and engineering? 1.78K viewsFDA 0 Votes 1 Ans How will the CMO handle your production plan? 1.60K viewsFDA 0 Votes 1 Ans Can the CMO provide staffing charts? 1.74K viewsFDA 0 Votes 1 Ans Does the CMO foster continuous improvement? 1.72K viewsFDA 0 Votes 1 Ans Is the CMO’s work culture compatible with yours? 1.50K viewsFDA 0 Votes 1 Ans Is there potential for automated processes? 1.46K viewsFDA 0 Votes 1 Ans Is the CMO financially stable? 1.57K viewsFDA 0 Votes 1 Ans Are the CMO’s facilities a good fit for your product? 1.63K viewsFDA 0 Votes 1 Ans Who is the contracting entity? 1.95K viewsFDA 0 Votes 1 Ans The transition period doesn’t end until May 2020. Why start now? 1.80K viewsFDA « Previous 1 2 … 66 67 68 69 70 … 75 76 Next » Question and answer is powered by anspress.net
