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Device Week, 12 June 2020 – New Insights Into FDA’s Quality System Reg Rewrite
On this week’s podcast we discuss some recent news out of the US FDA about its efforts to harmonize its Quality System Regulation with international quality systems standard ISO 13485.
More from Regulation
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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
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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.
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Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.
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Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
More from Policy & Regulation
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Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
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The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
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The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.