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Compliance 360° Part 1: Handling Difficult US FDA Investigators

 
• By Shawn M. Schmitt

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this first installment, former FDA investigations branch director Ricki Chase explains how you should handle a difficult agency investigator who shows up at your facility door.

MT1701_Compliance360
Other Compliance 360° Podcasts

When Ricki Chase worked at US FDA, she witnessed some truly bizarre behavior from agency investigators.

“Throughout my years, I had numerous opportunities to train and to audit the investigators, and noted attitudes and behaviors that could’ve been perceived by our partners in industry as aggressive,...

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Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

More from Policy & Regulation

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel