All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-P-3103
Requests that the FDA classify APAP machines as Over-The-Counter, provided they are limited to a maximum pressure of 10 cm H2O.
Documents
38
Comments
0
Key Dates
Comment Period OpensMar 30, 2026
Documents
| Type | Title | Status |
|---|---|---|
Supporting Material |
Keywords
CDRH
Citizen Petition
classify
APAP machines as Over-The-Counter provided they
are limited to a maximum pressure of 10 cm H2O
OPEN
Data from Regulations.gov