1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

Market Fast Track Or Regulatory Trap? Consultant Ken Block On US FDA’s Breakthrough Devices Program

 
• By Ryan Nelson

Ken Block of Ken Block Consulting weighs in on the FDA’s Breakthrough Devices Program, its implications for raising capital, achieving speedier market access, and inviting more intensive regulatory scrutiny in this interview with Medtech Insight.

• Source: Shutterstock

Speaking with Medtech Insight on 29 August, medtech industry consultant Ken Block said he’d just wrapped a call with a client and a US Food and Drug Administration representative regarding the former’s novel medical device.

He explained, “It's a kind of a marketing-related call that FDA does” to say, “‘We’ve identified your company as having a novel device.’”

According to Block, founder and president of Richardson, TX-based Ken Block Consulting, device manufacturers that have approached the agency with a pre-submission may be recipients of these calls, as...

More from Regulation

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

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

More from Policy & Regulation

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

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.

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.