RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

The RAPS store will be under maintenance Saturday, 13 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > Books: Medical Device Development: A Regulatory Overview

Books: Medical Device Development: A Regulatory Overview

Posted 01 April 2009 | By

Although this book is almost nine years old, it is still relevant regarding historical content and the derivations of various regulations. There are 15 chapters that cover topics ranging from the 510(k) regulations and requirements through the Premarket Approval requirements, designing clinical studies for devices, the reclassification process and working with FDA.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.