FDA's Medical Technology Initiative

Originally Published MX September/October 2003

COVER STORY

Medtech manufacturers have not been neglected among the many initiatives launched by FDA under the direction of Commissioner McClellan. Early in the year, the agency announced a major new medical technology development initiative intended, in the commissioner's words, "to make sure we have regulatory processes that are as efficient and up-to-date as possible." The three main elements of the initiative are described below.

Reducing Cycle Time. The agency has conducted a root-cause analysis of recent multiple-cycle product approvals—products that required two or more rounds of review before they could be approved. "Often, multiple cycles do not appear to be FDA's fault," McClellan told the annual meeting of FDLI in April. "But in our preliminary analysis, it appears that in some cases, early communication and more transparency in our regulatory requirements might help avoid multiple cycles."