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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. 3640 Regulatory Class Class II Product Code DZE NHA Dated February 10 2017 Received March 16 2017 Dear Ms. Type of Use Select one or both as applicable Prescription Use Part 21 CFR 801 Subpart D Over-The-Counter Use 21 CFR 801 Subpart C CONTINUE ON A SEPARATE PAGE IF NEEDED. 97. For questions regarding the reporting of...
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What is argon med?
Argon med is a mandatory reporting form that collects information about medical devices sold in the market.
Who is required to file argon med?
Manufacturers, importers, and distributors of medical devices are required to file argon med.
How to fill out argon med?
Argon med can be filled out online through the designated platform provided by the regulatory authority.
What is the purpose of argon med?
The purpose of argon med is to track and monitor medical devices in the market to ensure their safety and effectiveness.
What information must be reported on argon med?
Information such as device identification, manufacturer details, adverse events, and sales data must be reported on argon med.
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