Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Who sponsors clinical trials? 1.63K viewsFDA 0 Votes 1 Ans What is a protocol? 1.58K viewsFDA 0 Votes 1 Ans What is a placebo? 1.74K viewsFDA 0 Votes 1 Ans What is a control or control group? 1.45K viewsFDA 0 Votes 1 Ans What are the different types of clinical trials? 1.64K viewsFDA 0 Votes 1 Ans What are the phases of clinical trials? 1.47K viewsFDA 0 Votes 1 Ans What is “expanded access”? 1.54K viewsFDA 0 Votes 1 Ans What changes to device registration and listing requirements became effective? 1.59K viewsFDA 0 Votes 1 Ans How do I update information for the owner/operator or official correspondent? 1.42K viewsFDA 0 Votes 1 Ans Do I have to add all of the proprietary names of my device? How many proprietary names can I add to my listing? 1.39K viewsFDA 0 Votes 1 Ans We currently have our in-house brand and we private-label for a number of companies in the U.S. Do we need to include the proprietary names for each private-label device? 1.54K viewsFDA 0 Votes 1 Ans Do we have to include all proprietary names that our listed device has ever been marketed under? 1.39K viewsFDA 0 Votes 1 Ans We do not have any proprietary names for our device, can we just fill in that field with the device type (e.g., a scalpel)? What alternative information will FDA accept in this field? 1.61K viewsFDA 0 Votes 1 Ans Should I include model numbers as part of the proprietary name? 1.50K viewsFDA 0 Votes 1 Ans How do I review the proprietary name information of my current device listings? 1.28K viewsFDA 0 Votes 1 Ans Is the Medical Device Excise Tax part of the Annual Registration User Fees? 1.41K viewsFDA 0 Votes 1 Ans Can an individual represent a foreign establishment as its U.S. agent and its official correspondent? 1.65K viewsFDA 0 Votes 1 Ans What is an O/O account responsible for? 1.55K viewsFDA 0 Votes 1 Ans What is an OC account responsible for? 1.45K viewsFDA 0 Votes 1 Ans How do I tell what kind of account I am logged in with? 1.49K viewsFDA « Previous 1 2 … 259 260 261 262 263 … 283 284 Next » Question and answer is powered by anspress.net
