Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans I am a foreign medical device manufacturer. Does the U.S. FDA UDI Rule apply to me? 1.32K viewsFDA 0 Votes 1 Ans Is it true that the U.S. FDA UDI Rule sunsets NDC/NHRIC codes for medical devices? 1.24K viewsFDA 0 Votes 1 Ans What’s going to happen to my Labeler Code? 1.32K viewsFDA 0 Votes 1 Ans What about global regulations and regulators? 1.33K viewsFDA 0 Votes 1 Ans Did the U.S. FDA UDI Rule mandate specific PIs? 1.47K viewsFDA 0 Votes 1 Ans What PI(s) should I use on our device packages and labels? 1.42K viewsFDA 0 Votes 1 Ans What if there are several PIs on our device labels? Which do I need to include in the UDI? 1.32K viewsFDA 0 Votes 1 Ans I have a UPN. Is that the same as UDI? 1.33K viewsFDA 0 Votes 1 Ans Can I use U.P.C. numbers as my UDIs? 1.40K viewsFDA 0 Votes 1 Ans Where do I get UDIs for my products from? 1.48K viewsFDA 0 Votes 1 Ans Do individual single-use devices (SUDs) packaged together need a UDI? 1.34K viewsFDA 0 Votes 1 Ans Do repackaged products require a UDI? 1.37K viewsFDA 0 Votes 1 Ans Do repackaged products have the original manufacturer UDI or the repackager UDI? 1.29K viewsFDA 0 Votes 1 Ans Since the COW laboratories are not routinely inspected, how will CMS approach these laboratories? 1.54K viewsClinical Research 0 Votes 1 Ans What was the reaction to the educational surveys in the expanded pilot? 1.70K viewsClinical Research 0 Votes 1 Ans Will COW laboratories close because of these visits? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans What else is CMS doing to assure quality testing in COW laboratories? 1.70K viewsClinical Research 0 Votes 1 Ans Does the U.S. FDA UDI Rule apply to hospitals? 1.37K viewsFDA 0 Votes 1 Ans The U.S. Food and Drug Administration issued the first cybersecurity guidelines for medical devices. What’s in them? 1.47K viewsFDA 0 Votes 1 Ans What is UDI? 1.21K viewsFDA « Previous 1 2 … 214 215 216 217 218 … 283 284 Next » Question and answer is powered by anspress.net
