ISO 13485 7.6
Control of monitoring and measuring equipment
ISO 13485 7.6 is the clause titled “Control of monitoring and measuring equipment” in ISO 13485, the medical device quality management standard. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 3 against 0 on the same dates in 2025
- Most often cited with
- ISO 13485 7.1, in 3 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 32026
What FDA writes when it cites it
The finding headings that cite ISO 13485 7.6 most often, as written in the letters.
- 1 letterFailure to adequately document procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner consistent with monitoring and measurement requirements, as required by ISO…
- 1 letterFailure to document procedures for the validation of the application of computer software used for the monitoring and measurement of requirements, as required by ISO 13485:2016, Clause 7.6
- 1 letterFailure to perform calibration or verification of measuring equipment in accordance with documented procedures, as required by ISO 13485:2016, Clause 7.6
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 7.6.
- ISO 13485 7.1Planning of product realization3 letters cite both
- ISO 13485 7.3.1General2 letters cite both
- ISO 13485 7.4.1Purchasing process2 letters cite both
- ISO 13485 8.5.2Corrective action2 letters cite both
- 21 CFR 1010.2Certification1 letter cites both
- 21 CFR 1040.20Sunlamp products and ultraviolet lamps intended for use in sunlamp products1 letter cites both
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
- 21 CFR 801.3Definitions1 letter cites both
Latest letters citing it
The 3 letters citing ISO 13485 7.6 that FDA posted most recently.
- DevicesView Unilam Co., LTDSUV 600-800/KT/GYU UV SunlampIssuedSep 22, 2026PostedOct 6, 2026
- DevicesView Nipro Renal Solutions USA, CorporationDry and liquid hemodialysis dialysate concentrate solutionsIssuedJul 24, 2026PostedAug 18, 2026
- DevicesView Linemaster Switch Corporationfoot pedal accessories for medical devices, including Class II foot pedal controls used with Class IV medical lasersIssuedMay 27, 2026PostedJul 22, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.