By Sharonmoyee Goswami*
A pdf version of this article may be downloaded here.
I. Current Regulatory Framework for Genetic Diagnostic Tests and the Dangers of Increased Regulation
E. Historical Expansion of Regulation Has Been Alleviated by Commensurate Expansion in Patent and FDA-Mediated Data Exclusivity
1. Increase Requirements for Labeling and Genetic Counseling That Keep up with Developing Technology through Monthly Meetings
3. Create Mandatory Maximum Times for Class II and Class III Approval Processes or Increase the Scope of Class II Devices to Decrease Overall Approval Times