CPC comments on the CDRH Proposed Guidance Development Agenda for Fiscal Year 2013

The CPC proposed changes to CDRH’s guidance development agenda including that CDRH prioritize finalizing the following two draft guidance documents:

• The Draft Guidance for Industry and Food and Drug Administration Staff – Applying Human Factors and Usability Engineering to Optimize Medical Device Design.
• The Draft Guidance on Total Product Life Cycle: Infusion Pump – Premarket Notification [510(k)] Submissions.