About Lee Leichter Expertise Manufacturing, Outsourcing, Regulatory (FDA), Quality systems and problems, Exporting, Start-up Issues, strategic planning, Distribution, etc.
Experience Employment history: Over 25 years in the industry
Question I want to export CPAPs which are used for the treatment of sleep apnea. I want to know of what I need to know and who so I can sell these in the USA
Answer Scott,
In order to import and sell these devices in the USA you must make a registration to receive clearance to market from the FDA and also register your facility as an initial importer and maintain a minimal set of procedures.
Information on how to do this is available on the FDA device website (www.fda.gov/cdrh). Click on "Device Advice" for a gret deal of information on how to submit a 510k and register your faciilty.
This is what I do for a living so if you have additional questions, you can e-mail me directly at leichter@plbiomedical.com
