ISO 13485 7.3.9
Control of design and development changes
ISO 13485 7.3.9 is the clause titled “Control of design and development changes” 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 7.3.9 most often, as written in the letters.
- 1 letterFailure to adequately review, verify, validate, and approve design and development changes before implementation, as required by ISO 13485:2016 Clause 7.3.9
- 1 letterFailure to document procedures to control design and development changes, and determine the significance of these changes to function, performance, usability, safety and regulatory requirements for the medical device…
- 1 letterFailure to document procedures to control design and development changes, as required by ISO 13485:2016, Clause 7.3.9
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 7.3.9.
- ISO 13485 7.1Planning of product realization3 letters cite both
- ISO 13485 7.4.1Purchasing process2 letters cite both
- ISO 13485 8.5.2Corrective action2 letters cite both
- 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 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 803.18What are the requirements for establishing and maintaining MDR files or records that apply to me?1 letter cites both
Latest letters citing it
The 3 letters citing ISO 13485 7.3.9 that FDA posted most recently.
- DevicesView Lion Street Medical, d/b/a Pensar Medical LLCWoundPro Negative Pressure Wound Therapy (NPWT) System, WoundPro+ NPWT System, and MicroDoc (PocketDoc) Portable NPWT SystemIssuedAug 21, 2026PostedSep 22, 2026
- DevicesView Nipro Renal Solutions USA, CorporationDry and liquid hemodialysis dialysate concentrate solutionsIssuedJul 24, 2026PostedAug 18, 2026
- DevicesView Koven Technologies, Inc.Bidop 3 DopplerIssuedJul 21, 2026PostedAug 4, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.