Medical Device Development: A Regulatory Overview 2000

A comprehensive reference with analyses of the U.S. medical device development and approval requirements that will help you succeed in the new era of medical device regulations. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device regulations in the U.S.

This text goes beyond rehashes of device law and regulation to present "real world" strategic advice for expediting product clearances and dealing with the Center for Devices and Radiological Health (CDRH). This practical guide provides detailed analysis on each step of the device development and approval process, and offers genuine insights into the best course of action given the prevailing trends in the current regulatory environment. Medical Device Development: A Regulatory Overview even alerts you the trends that are likely to be harbingers of future changes to the clearance process.

Only in this report will you find strategic advice and guidance from a 20-year regulatory veteran with an insider's view into CDRH's medical device approval process.

Features include insight into the acceptability of foreign clinical data, what the FDA says are the most common biostatistical errors in PMA applications, the dos and don'ts of reclassification, and key trends relating to intercenter jurisdictional committees and combination products.