Welcome to Compliance Consultants...

...the more you learn...the more you will want us for FDA!

Effectiveness...

You must establish the device is capable or effective in accomplishing it stated purpose. This relates to the overall design and how the design fits the application. Often a Class II device is determined effective if it meets a performance standard. Where no performance standard applies often the submission must be handled carefully otherwise the FDA may ask a question that is calculated to cause you to conduct a clinical trial or clinical investigation.

Although clinical trials are NOT required for Class II devices, there is a shift in FDA views that lean toward requiring a clinical trial where they can to establish effectiveness.

copyright by Compliance Consultants, Stamford, CT USA, September 2001