Jun 17, 2011

The FDA’s Center for Devices and Radiological Health (CDRH) has published a standard operating procedure (SOP) clarifying its process for publishing and distributing Notice to Industry letters notifying manufacturers of changes to regulatory expectations.

In particular, the CDRH SOP covers Notice to Industry Guidance and Notice to Industry Advisory letters that would address new scientific data that would change requirements submissions including Investigational Device Exemptions, 510(k)s, Premarket Approvals and Humanitarian Device Exemptions. The CDRH will post Notices on its website, and employ “additional methods” of distribution to appropriate parties, according to the SOP.

The new SOP was developed in response to recommendations published in August 2010 by the Task Force on the Utilization of Science in Regulatory Decision Making; the task force pointed out that the CDRH should make use of more rapid and efficient communication tools, as well as establish standard practices for issuing Notice to Industry letters.

Under the current notification process, manufacturers usually only learn of regulatory changes when they interact individually with the CDRH—often as they begin their premarket submission efforts. If the CDRH issues any detailed guidance on a regulatory change, publication of the guidance may come as late as a year after actual implementation, due primarily to “resource constraints in developing guidance documents,” according to the agency.


  • Stewart Eisenhart