CDRH, Industry to Discuss Collaboration on HHE and Recalls

By MedTech Intelligence Staff
April 29, 2016


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, RC - Medical Device Audits, Certification & Verification

So many questions swirl around recalls. When should a health hazard evaluation (HHE) be initiated? Is FDA’s HHE process different from industry’s approach? How should one estimate risk? Who are the key players in the process? What are the best practices for communication, especially on an external level?

CDRH officials, including Ron Brown, director of the recall branch at the Office of Compliance, and industry stakeholders will answer these questions at the upcoming MedTech Intelligence HHE and Recalls Conference (View the agenda), May 10–11, 2016 in Washington, DC.

What’s new this year:

• FDA update on recall and field action trends and observations
• eSubmitter and 806 reports
• New initiatives pertaining to recalls: Benefit-risk, program alignment, Case for Quality
• Draft guidance on Emerging Signals and Early Recall Notifications
• Presentation on internal FDA HHE procedures
• Detailed FDA-industry discussion and analysis of representative HHE case studies
• Ongoing evaluation and effectiveness checks of recalls
• Managing expanding recalls (a.k.a. Recall Do-overs)

This event will be followed by a one-day Global Recalls conference on May 12. More than half of all medical device recalls involve two countries or more. Streamlining the recall process while minimizing costs and mitigating adverse repercussions requires advanced knowledge, thought and planning. The conference will feature an overview of the regulatory landscape, FDA’s perspective on international recalls, HHE and risk acceptability, and global recall strategies and immediate actions.