Getting FDA Pre-Market Approval

Hello,

My company is a fairly new medical device company, and currently looking to gain access in to the US market. I would like some guidances and/or resources (links) on how to acquire FDA pre-market approval.

Thanks

 

Hi Amaka

The best place to start is probably the Medical Device section of the FDA web-site. There are a lot of guidance documents available here.

I suggest page called "How to Study and Market Your Device" as a starting point. The links from this page should tell you much of what you need to know.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm

Chris