Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to adequately establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm does not have a design control procedure that details design input, design output, design verification, design validation, design transfer, design review, and design history, specifically:
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 803.17
- 21 CFR 803
- 21 CFR 820.70(g)
- 21 CFR 820.75(a)
- 21 CFR 820.30(a)
- 21 CFR 820.30
- 21 CFR 820.100(a)
- 21 CFR 820.90
- 21 CFR 820.50