Medical Device Development: A Regulatory Overview

Barnett Educational Services
March 1, 2000
400 Pages - SKU: BNT1870225
License type:
Now there is a practical reference guide to help you succeed in the new era of device regulation — Medical Devices Deployment: A Regulatory Overview is the most comprehensive and up-to-date reference for today's medical device approval program. Unlike other publications, this report 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 Devices Deployment: A Regulatory Overview even alerts you to the latest emerging issues and 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.

Consider these report features:

  • Two years after the release of the Temple Report, new interpretations continue to impact medical device development. Find out the latest trends spawned from this report.
  • Get insight into the acceptability of foreign clinical data.
  • Find out what the FDA says are the most common biostatistical errors in PMA applications.
  • Contemplate the dos and don'ts of reclassification.
  • Identify key trends relating to intercenter jurisdictional committees and combination products.
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