21 CFR 801.5
Medical devices; adequate directions for use
21 CFR 801.5 is the regulation titled “Medical devices; adequate directions for use” in 21 CFR Part 801, Labeling. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 801.109, 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
- 12023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 801.5 (eCFR, as of Sep 1, 2026)
Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specification of:
(a) Statements of all conditions, purposes, or uses for which such device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner.
(b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions.
(c) Frequency of administration or application.
(d) Duration of administration or application.
(e) Time of administration or application, in relation to time of meals, time of onset of symptoms, or other time factors.
(f) Route or method of administration or application.
(g) Preparation for use, i.e., adjustment of temperature, or other manipulation or process.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 801.5.
- 21 CFR 801.109Prescription devices1 letter cites both
- 21 CFR 803.12How do I submit initial and supplemental or followup reports?1 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 803.3How does FDA define the terms used in this part?1 letter cites both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1 letter cites both
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
Latest letters citing it
The letter citing 21 CFR 801.5 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.