Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans When will the NCT Number for my study be assigned? 1.50K viewsFDA 0 Votes 1 Ans Can I register a study after it has started, has closed to recruitment, or has been completed? 1.49K viewsFDA 0 Votes 1 Ans Must clinical studies with no external sources of funding (“unfunded” studies) be registered on ClinicalTrials.gov? 1.84K viewsFDA 0 Votes 1 Ans How do I contact ClinicalTrials.gov if I have a question about my study record? 1.57K viewsFDA 0 Votes 1 Ans Do I need to register each single-patient investigational new drug application (IND) or protocol exception (including for emergency use) separately? 1.63K viewsFDA 0 Votes 1 Ans Can an organization have multiple users for a single account? 1.46K viewsFDA 0 Votes 1 Ans Can registration and results information be uploaded electronically to ClinicalTrials.gov? 1.46K viewsFDA 0 Votes 1 Ans To comply with FDAAA 801, must I submit information to ClinicalTrials.gov, or can I use another registry or results database? 1.72K viewsFDA 0 Votes 1 Ans To comply with FDAAA 801, must I submit information to ClinicalTrials.gov, or can I use another registry or results database? 1.49K viewsFDA 0 Votes 1 Ans Does FDAAA 801 only apply to industry-sponsored studies? 1.76K viewsFDA 0 Votes 1 Ans Does the definition of applicable clinical trial under FDAAA 801 only include studies conducted under an FDA Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)? 1.65K viewsFDA 0 Votes 1 Ans Where do we send the portfolio plan? 1.44K viewsFDA 0 Votes 1 Ans What are the differences between MEDDEV 2.7.1 Rev. 4 and MDR clinical evaluation requirements? 1.71K viewsFDA 0 Votes 1 Ans Is there a template that could be used for CER that is in compliance with the new MDR? Considering Adverse event database for a device…would not the device sales be the denominator? If a competitor’s device is similar, for example, to a hemodialysis catheter, can literature about that device be used or excluded? Is a contract required to use that data? 1.69K viewsFDA 0 Votes 1 Ans Do we really need to gain access to our competitor’s technical files to show equivalence for the CERs? 1.66K viewsFDA 0 Votes 1 Ans Is the Clinical Evaluation Plan the best place to document our position on our CER approach and gain alignment with the Notified Body as needed? 1.48K viewsFDA 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 Intended use vs. indications for use. Some older products do not have indications for use. Do you need to redefine intended use to include all indications, or can you use a risk-based approach and use evidence for one high risk indication? 1.51K 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 « Previous 1 2 … 253 254 255 256 257 … 283 284 Next » Question and answer is powered by anspress.net
