ISO 13485 8.3.1
General
ISO 13485 8.3.1 is the clause titled “General” 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
- 21 CFR 801.20, 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 8.3.1 most often, as written in the letters.
- 1 letterFailure to ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery; and failure to document a procedure defining the controls and related…
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 8.3.1.
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
- 21 CFR 801.3Definitions1 letter cites both
- 21 CFR 801.40Form of a unique device identifier1 letter cites both
- 21 CFR 830.3Definitions1 letter cites both
- 21 CFR 830.300Devices subject to device identification data submission requirements1 letter cites both
- ISO 13485 6.3Infrastructure1 letter cites both
- ISO 13485 7.1Planning of product realization1 letter cites both
- ISO 13485 7.3.1General1 letter cites both
Latest letters citing it
The letter citing ISO 13485 8.3.1 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.