FDA Registration FAQs

Nov 24, 2014

Below is an FDA requirements cheat sheet with our frequently asked questions. If you are still confused, or looking for more answers, Applied can take the hassle away and register for you! Just give us a call for more information, 1-888-327-7301.
 

How do I know if I have to register with the FDA?
Anyone who fills, or private labels the gas MUST register. (21 CFR 207.20)

How often is it required to register?
Registration must be done annually, and it must be submitted between October 1 and December 31 of the year. (21 CFR 207.21(a), 21 USC 360(b))

Should I register before I begin transfilling, or should I wait until my system is operating?
Registration must be done within 5 days of starting filling. (21 CFR 207.21 (a))

Can I register without filling out the drug listing?
Everyone who registers must do a drug listing. (21 CFR 207.21 (a)) You only submit a drug listing, after the initial reporting, if there are updates. (21 CFR 207.30(b))

Why didn't the FDA assign me an FEI number?
The FDA may assign an FEI number to each establishment. If it doesn't, you can use that location's DUNS number.

You Might Also Like

Categories
Oxygen (62)
Equipment (54)
Regulatory Compliance (42)
OxyGo (31)
Oxygen Safety (29)
Business (22)
General (22)
Training Education (16)
Industry News (13)
Events (10)
Medical Oxygen (6)
Financing (4)
Technology (4)
Regulators (2)
Safety (2)
Oxysafe (2)
Compliance (2)
Oxygen Equipment (2)
Cylinders (2)
DME (2)
HME (2)
Training (2)
OxySafe2 (2)
COVID 19 (2)
Procedures (1)
Press Release (1)
Emergency Oxygen (1)
Policy (1)
Poc (1)
Acquisition (1)
LIFE Corporation (1)
Regulator Testing (1)
Healthcare Industry (1)
DOT (1)
FDA (1)
Manuals (1)
OxySafe (1)
SOPS (1)
Registration (1)
Sleep Apnea (1)
Sleep (1)
New Product Award (1)
HME Business (1)
Medtrade (1)
Tradeshows (1)
CARES (1)
Drug Reporting (1)
Fda (1)
CGMP (1)
Natural Disaster (1)
Cga (1)
Cylinder Safety (1)
Thermal Shut Off (1)
Safety Training (1)
Cleaning Solutions (1)
Oxygen Cylinders (1)
FDA Approved (1)
Leak Testing (1)
Required Training (1)
Gauges (1)
At Home (1)
Chemicals (1)
COVID19 (1)
USDOT (1)
Marquard Schultz (1)
Marquard (1)
CEO (1)
Award (1)
Smart 50 (1)
Oxygen Service (1)
MEDICAL OXYGEN (1)
Disinfecting (1)
Cleaning (1)
Information Technology (1)
IT (1)
Pandemic (1)
Coronavirus (1)
COVID (1)
MEDICAL GAS (1)
CYLINDERS (1)
Compressed Gas (1)
Regulations (1)
Infection Control (1)
Covid 19 (1)
Disinfectant (1)
Thermal Shut Off Device (1)
Pigtails (1)
Calibration (1)
Servomex (1)
Storing (1)
Expo (1)
Transporting (1)
Rules (1)
Compressed (1)
Gas (1)
Respiratorytherapist (1)
Ceu (1)
Education (1)
CPAP (1)
+ Show More

Subscribe to our Email List

Get the latest regulatory info, accreditation news and exclusive discounts!

Loading Form...
© , Applied Home Healthcare Equipment. All rights reserved. Design by Premier Designs. Powered by Virteom