label information

  1. E

    CSR SHIPPING - Need suggestions for making SOP/WI for our shipping dept (automotive)...

    We are getting written up for various shipping/labeling failures. We just lost the lead shipper (who was OK, but not great in appeasing the big automotive suppliers). Now that he is gone, we are getting more complaints and fines. Our Quality Manager has decided the Quality Department needs to...
  2. T

    FDA proposed labeling standalone software cloud based

    So, we are currently preparing a 510(k) submission for our medical device which is basically a stand-alone medical software cloud-based. Our biggest issue at the moment is the proposed labeling - how to tackle it. Obviously, some things are pretty much constant, like IFU, IU, directions for...
  3. R

    IEC 60601-2-57 - Subclause 201.7.101.2 - Explanatory Label - LS Equipment

    Subclause 201.7.101.2 states "LS EQUIPMENT classified in excess of the Exempt Group shall carry an explanatory label (Fig. 201.101)" and in accordance with table DD.1, from annex DD, equipment classified in the "Exempt Group" shouldn't require any labeling. But, subclause 201.7.101.4 asks for...
  4. I

    Requirements for different Labeling Levels

    For the following three examples: Gloves do not have individual packaging. 100 gloves are provided per box Each suture is sealed in a pouch. 10 pouches are provided in a box. Each graft is sealed in a pouch. 1 pouch is provided in a box. For example 1 it's sufficient to only place labeling...
  5. S

    What is the significance of UDI date requirements for Class 1 devices?

    FDA issued a guidance establishing enforcement discretion that applies to FDA established compliance dates for certain class I and unclassified devices as set out below: Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018 FDA does not intend to enforce...
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