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Regulatory News In Brief

IMDRF releases three new proposed guidance documents. FDA is accepting comments on its plans to accept electronic submissions for device recalls. More regulatory news.

The International Medical Device Regulators Forum issued three new draft guidance documents July 1. The first guidance outlines key definitions for standalone medical device software. The other two come from the Medical Device Single Audit Program work group. One describes competency and training requirements for regulatory authorities undertaking assessments of auditing organizations. The other explains the assessment strategy regulatory authorities should use when recognizing and monitoring medical device auditing organizations. The Medical Device Single Audit Program work group also released two guidances in April related to the single audit program. (See Also see "IMDRF Issues Proposed Guidances On Device Auditors, Global UDI System" - Medtech Insight, 22 April, 2013..) Comments on all three guidance documents are due Aug 30.

FDA announced June 28 that it is accepting public comments on its plan to allow electronic submission of corrections and removals reports, known as 806 reports. The reports would be...

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EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

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

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

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

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

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.