FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Did the U.S. FDA UDI Rule mandate specific barcodes or AIDC methods? 1.34K viewsFDA 0 Votes 1 Ans Will my U.P.C. barcode satisfy UDI labeling requirements? 1.43K viewsFDA 0 Votes 1 Ans Do the components or constituent parts of kits/combination products need a UDI? 1.49K viewsFDA 0 Votes 1 Ans Can we encode additional information in a GS1 barcode that is being used for UDI? 1.43K viewsFDA 0 Votes 1 Ans What is the standardized date format in the U.S. FDA UDI Rule? 1.17K viewsFDA 0 Votes 1 Ans Is the UDI standardized date format the same as the ISO standard? 1.28K viewsFDA 0 Votes 1 Ans What if we don’t specify the day in our expiration dates (or production dates)? 1.34K viewsFDA 0 Votes 1 Ans When does the new date standard go into effect? 1.31K viewsFDA 0 Votes 1 Ans Do all devices need to be directly marked with their UDI? 1.24K viewsFDA 0 Votes 1 Ans When do direct marking requirements go into effect? 1.27K viewsFDA 0 Votes 1 Ans Who is responsible for submitting UDIs to the GUDID? 1.24K viewsFDA 0 Votes 1 Ans What needs to be submitted to the GUDID? 1.29K viewsFDA 0 Votes 1 Ans What methods are available for reporting UDIs and the associated data to the GUDID? 1.19K viewsFDA 0 Votes 1 Ans Will the GUDID record PI information (such as specific serial numbers and lots) for every item? 1.12K viewsFDA 0 Votes 1 Ans When do I have to submit our UDIs and data to the GUDID? 1.25K viewsFDA 0 Votes 1 Ans Does the U.S. FDA UDI Rule apply to hospitals? 1.14K viewsFDA 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 « Previous 1 2 … 59 60 61 62 63 … 75 76 Next » Question and answer is powered by anspress.net