Sam Lazzara
Trusted Information Resource
The MDD requirement shown below could be interpreted in a couple ways.
13.6. Where appropriate, the instructions for use must contain the following
particulars:
(q) date of issue or the latest revision of the instructions for use.
Must the IFU always contain a date, or is it acceptable if the IFU indicates the latest revision by another method, such as a letter revision? My interpretation is that a date is always required.
I have a colleague that is interpreting this to mean that another method of revision indication, such as a letter revision, would be sufficient.
Any informed opinions on this?
Does the latest MDD have a "preamble" or the like that provides context for this and other requirements?
Per USA 21 CFR 801.109(e): All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
This is more clearly written and I suspect this is what is meant by the MDD requirement 13.6(q).
Thank you
Sam Lazzara
13.6. Where appropriate, the instructions for use must contain the following
particulars:
(q) date of issue or the latest revision of the instructions for use.
Must the IFU always contain a date, or is it acceptable if the IFU indicates the latest revision by another method, such as a letter revision? My interpretation is that a date is always required.
I have a colleague that is interpreting this to mean that another method of revision indication, such as a letter revision, would be sufficient.
Any informed opinions on this?
Does the latest MDD have a "preamble" or the like that provides context for this and other requirements?
Per USA 21 CFR 801.109(e): All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
This is more clearly written and I suspect this is what is meant by the MDD requirement 13.6(q).
Thank you
Sam Lazzara
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