CDRH
Quick Stats: CDRH Releases Annual Complaints Report
Jan 25, 2012
Industry wasn’t shy about lodging complaints to CDRH this year. The center released its annual report today. Among 461 reported contacts (53% of which...
FDA Is Now Blogging
Jan 03, 2012
Just before Christmas, FDA debuted a new blog named "FDA Voice." The inaugral post was written by FDA administrator Margaret Hamburg, who...
When Reason Meets the Absurd: A Quick Look at FDA and CDRH in 2011
Dec 18, 2011
While FDA (CDRH) and the medical device industry have a long history of antagonism, the relationship seemed to become especially sour in 2011. The agency has...
Misunderstanding of FDA Device Classification Is Widespread
Dec 09, 2011
The device classification scheme is an important component of the U.S. regulatory system for medical technology. Introduced in the Medical Device...
This Week in Devices: Qualcomm Steps Up its Wireless Health Involvement
Dec 09, 2011
This week in devices, a Minnesota trade group signed a deal with CDRH to speed device approvals and MD+DI's full salary survey results were released. Also,...
Why Don't CDRH Reviewers Always Greet You Warmly on the Phone? They Are Stressed, Says Former FDA Insider
Dec 06, 2011
At a conference session at Biomedevice at San Jose, president of CardioMed Device Consultants (Baltimore) Semih Oktay, PhD gave a broad overview of CDRH ...
CDRH Director Shuren to Speak at LifeScience Alley
Dec 05, 2011
Center for Devices and Radiological Health (CDRH) director Jeffrey Shuren, MD will deliver a keynote address at the LifeScience Alley Conference & Expo...
Correlation vs. Causation: What's Behind the Slowdown in Medtech's Growth Rate?
Dec 04, 2011
We recently posted some data reflecting that the device industry's growth is slowing as is the FDA's average review times. That post generated a comment from...
HELP Hearing on Medical Devices
Nov 15, 2011
Senator Mike Enzi. Photo courtesy of U.S. Senate. The U.S. Senate Committee on Health, Education, Labor, and Pensions today held a hearing on medical...
MD+DI Exclusives: All About Taxes, CDRH Wants to Work with You, and Quality Validation
Jul 26, 2011
This week at mddionline.com, Brian Buntz has a discussion going about the infamous device excise tax and whether it will be as disastrous as some fear;...