This week's live streaming video is about how to use labeling checklists for the review and approval of medical device labeling.
The best way to review and approve labeling content is to create a labeling checklist for each of the regulatory requirements that are applicable to your device. There are five sources that we review in this video:
- 21 CFR 801 - www.accessdata...
- SOR 98/282, Sections 21-23 - laws-lois.just...
- Regulation (EU) 2017/745, Annex I, sections 23.1-23.4 - eur-lex.europa...
- ISO 20417:2021 - www.evs.ee/et/...
- ISO 15223-1:2021 - www.evs.ee/et/...
If you are creating a new label for a new device, then you would review and approve this label as part of design controls (SYS-008) prior to your design freeze (i.e. before design verification and validation). If you make any changes after that to a label or instructions for use, then you should use the change control process (SYS-006) to make sure that any changes are revalidated.
- SYS-006 Change Control - medicaldevicea...
- SYS-008 Design Controls - medicaldevicea...
In your labeling checklist you should have a table with one line for each requirement. The column next to the requirements should indicate where the requirement is addressed in your labeling, or a justification for non-applicability should be provided.
If you are interested in purchasing our labeling procedure along with our checklists, please visit our website to purchase SYS-030 - medicaldevicea...
If you purchase the procedure before we split it into two procedures, you will receive the current procedure titled "Labeling and Translations" and you will also get the updated labeling procedure later in February 2022. The Translation procedure (SYS-052) will be released a little later in February 2022 or March 2022.
If you are interested in learning more about labeling in the future (i.e. February 28), we are hosting a live webinar on "How to write instructions for use (IFU)." Here's a link for registering for that webinar:
- medicaldevicea...
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