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

Newman Out As CDRH Compliance Chief, Maisel In As Acting Director

 
• By Shawn M. Schmitt

Robin Newman is out as director of the Office of Compliance within US FDA's device center, leaving the post after only 18 months on the job. Agency stalwart Bill Maisel has taken her place on an "acting" basis as he leads the effort to create a "super office" that will merge the compliance office, the Office of Surveillance and Biometrics, and the Office of Device Evaluation into one.

Top FDA officials including Jeff Shuren (left), Robin Newman, Thomas Gross and Bill Maisel answered industry questions at The Medtech Conference 2017 which was moderated by AdvaMed’s Janet Trunzo.
Robin Newman (second from left) answers questions with top CDRH officials, including William Maisel (second from right), at The Medtech Conference in September. • Source: Ferdous Al-Faruque

Robin Newman is out as director of the Office of Compliance within US FDA's device center, leaving the post after only 18 months on the job. Agency stalwart and top scientist Bill Maisel has been named as acting head.

Newman left FDA on Oct. 20 to join Johnson & Johnson's device unit as worldwide VP for clinical research and development, returning to the device industry from where she...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Compliance

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process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The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry.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.

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

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.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

More from Policy & Regulation

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

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.

Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

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.

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

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.