ISO 13485 8.3.4
Rework
ISO 13485 8.3.4 is the clause titled “Rework” in ISO 13485, the medical device quality management standard. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- ISO 13485 6.4.1, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
What FDA writes when it cites it
The finding headings that cite ISO 13485 8.3.4 most often, as written in the letters.
- 1 letterFailure to perform rework in accordance with documented procedures that take into account the potential adverse effect of the rework on the product, as required by ISO 13485:2016, Clause 8.3.4
The standard
This is a clause reference cited in an FDA letter. Full ISO 13485:2016 text is not reproduced here. Read the standard for the complete requirements.
Cited alongside it
Regulations that appear in the same letters as ISO 13485 8.3.4.
Latest letters citing it
The letter citing ISO 13485 8.3.4 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.