labels and labeling (general)

  1. Barryjogorman

    Practical ideas for information labelling in healthcare environment

    Wrt electronic docs - labels in doc name or in doc meta data. Also, what about email?
  2. G

    How is the labeling of units cleared for both Rx and OTC uses handled?

    Hello, For a unit which 510(k) has both the "Prescription Use" and the "Over-The-Counter Use" checked on its 510(k) summary - how is the labeling supposed to be handled? - one set of artwork for the OTC unit ... a version without Rx functions enabled or claimed? - a separate set of artwork for...
  3. Ajit Basrur

    How do I label this commercial product ready for clinical study?

    We have a commercial product that will be supplemented with features that will eventually make the final product fall under a medical device and requiring clinical trials. How do I label this commercial product ready for clinical study - I presume the product name definitely has to be removed to...
  4. D

    Label Legibility on Handheld Devices

    Recently had several devices reviewed for IEC 60601-1 compliance and "failed" or needed additional information regarding clause 7.1.2 legibility. One device is a tabletop computer console and the other two devices are attached by a plug in cord to the tabletop unit and the user holds each one in...
  5. M

    Scrubbed version of a labeling procedure that is MDR compliant wanted

    Hi, Can someone share a scrubbed version of their labelling procedure that is MDR compliant. Also, what would you suggest for FDA labeling process. Should we add that in the existing SOP? Thanks!
  6. S

    Expiration Date (use by date) on a product label

    I recall hearing or reading that the MDR will be requiring the expiration date (use by date) on a product label to include the day of the month, using the format of yyyy-mm-dd. Is that correct, or can it continue to be just the year and the month? I should mention that the date is on an entire...
  7. M

    Over-labelling - Any requirements or best-practices?

    Situation: Our manufacturer address changes. Because the large stock of labels, packaging, and printed manuals that all have the old address, we are considering over-labelling (applying a label with the new address over the old address, but otherwise other labelling content is unaffected). A...
  8. 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...
  9. Q

    What tier number fits in a company producing paper labels stuck on automotive parts?

    Hi everyone What tier number fits in a company producing paper labels stuck in automotive parts? And What mandates? Iatf rules or customer rules? Thanks
  10. L

    EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content

    Hi all, I was hoping to get some guidance regarding the labelling requirements for devices/ articles which contain CMRs or substances with endocrine-disrupting (ED) properties. I understand that where there is a concentration above 0.1% w/w, a reference to these substances must be made on the...
  11. L

    Document review is a kind of verification?

    hello, I have a quesiton about verification method. Is the reviewing of doucment an approach of verification? for example , certain content of an identification label of system is changed, the drawing of the lable will be reviewed as DMR documents. Is the reviewing process as design...
  12. 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...
  13. S

    Medical Device Research Use Only (RUO) label

    Dear all, I am a rather beginner in the regulatory affairs for IVD diagnostics and some questions which will come from my side may sound quite naive. We want to offer our products now also as RUO products. We have adapted the technical file, the SDS and now I want to adapt the labels. Having...
  14. 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...
  15. supadrai

    Indemnity Letters - What's the Deal?

    We have a customer who wants us to create one package that we they can use in both the U.S. and the EU. For the EU, one of the claims they want to make on the packaging is unsupported by our current test results so we said we can't put it on the packaging. They offered up an indemnity letter...
  16. Marcelo Antunes

    Medical Device News FDA Withdrawals Two Proposed Rules

    FDA Withdrawals Two Proposed Rules Laser Products; Proposed Amendment to Performance Standard (FDA-2011-N-0070) Electronic Submission of Labeling for Certain Home-Use Medical Devices (FDA-2016-N-2491) Federal Register :: Public Inspection: Laser Products: Performance Standard and...
  17. 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...
  18. S

    Symbols - Device label versus Packaging label

    Hi everyone, I have a labeling question. A company declares conformity to ISO 15223 for symbols to used with medical device labels. The information on the device packaging label (the outer packaging that protects the device during shipping) however does not show all the symbols on the...
  19. M

    EN 374-2 One time test and labelling

    Hi All, We are going to launch a new product similar to an examination glove. The glove is meant to be used for patient bed-bathing and keeps the user safe from cross contamination during the procedure. Our supplier has conducted a one-off EN 374-2 test to show that the glove is...
  20. K

    Label - IFU requirement, maybe?

    Good Morning, I have a quick question that I am hoping someone can help me with. I am evaluating one of our suppliers' IFU for a distributed product. I know on our IFUs we include page numbers, document number and current revision, and date of last revision. Is there a requirement...
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