Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
No separately extracted passage is available. Read the original FDA letter for the full text.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 803.11(a)
- 21 CFR 803.17
- 21 CFR 803.17(a)(1)
- 21 CFR 803.3(o)(2)(ii)
- 21 CFR 803.17(a)(3)
- 21 CFR 803.17(b)
- 21 CFR 803
- 21 CFR 807.81(a)(3)(i)
- 21 CFR 807.81(a)(1)
- 21 CFR 807.81(a)(3)
- 21 CFR 807.81(b)
- 21 CFR 820.100(a)
- 21 CFR 820.198(e)
- 21 CFR 862.1205