Medical Devices Today

"Plug And Play" Medical Systems Raise Complicated Regulatory Questions

Article prview reprinted from "The Gray Sheet" - February 1, 2009

FDA, device makers and others are struggling to identify the best way to regulate "interoperable" medical systems - such as an iPhone that receives blood glucose data - with some suggesting that a separate classification scheme might be needed. Read more...

Radiology Devices Move To OIVD: More Cohesive Dx Reviews Ahead?

Full article reprinted from "The Gray Sheet" - February 1, 2009

FDA hopes that shuttling its Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety will produce more cohesive policies on diagnostic device review. Read more...

Shuren's CDRH Sets Ambitious 2010 Agenda: 510(k), PMA Changes Planned

Full article reprinted from "The Gray Sheet" - January 25, 2009

CDRH launched an ambitious 2010 agenda Jan. 20 that includes changes to the 510(k) and PMA pre-market programs by this fall, harmonized international inspection activities by 2011 and unique device identifiers by 2013. Read more...

It's Official: Jeffrey Shuren Is New Device Center Director

Full article reprinted from "The Gray Sheet" - January 25, 2009

FDA and Jeffrey Shuren have made it official: the neurologist, lawyer and experienced FDA staffer was named director of the agency's Center for Devices and Radiological Health Jan. 20. Read more...

CDRH Taps Shuren As Permanent Head, Sets Ambitious 2010 Agenda

Breaking news alert reprinted from "The Gray Sheet" - January 20, 2010

FDA named Jeffrey Shuren as permanent device center director today, while launching an ambitious 2010 agenda that includes changes to the 510(k) and PMA pre-market programs by this fall, harmonized international inspection activities by 2011 and unique device identification by 2013.   Read more...

IN3 Webinar: “Capitalizing on Current FDA Guidance: The Promise and Perils of Disseminating Scientific Literature about Off-Label Use of Medical Devices”

IN3 Webinar

“Capitalizing on Current FDA Guidance: The Promise and Perils of Disseminating Scientific Literature about Off-Label Use of Medical Devices”

 

Thursday, February 11, 2010, 2:00-3:30 p.m. EST/11:00 a.m.-12:30 p.m. Pacific

FDA Advisory Committee Survival Strategies: The Road To Approval

NEW EBI Webinar: FDA Advisory Committee Survival Strategies: The Road To Approval

January 20, 2010 at 2:00 pm EDT Click Here To Register!

Getting a drug or medical device to market has never been more expensive, time-consuming, or difficult. New legislation increases the likelihood that your product will wind up in front of an FDA advisory committee. With the road to approval becoming even tougher, just having solid data to support your product may not be enough.

Knowing how to avoid common pitfalls, effectively present your story to an increasingly skeptical audience, and manage Q&A can make or break your new drug or device application.

In this Webinar (January 20 at 2:00 pm EDT) sponsored by "The Pink Sheet" and "The Gray Sheet" - our experts will take you through a strategic approach to preparing for an advisory committee that maximizes your chance of success, no matter your level of experience in this challenging process.

Click Here To Register!

Knowing how to avoid common pitfalls, effectively present your story to an increasingly skeptical audience, and manage Q&A can make or break your new drug or device application.

In this Webinar (January 20 at 2:00 pm EDT) sponsored by "The Pink Sheet" and "The Gray Sheet" - our experts will take you through a strategic approach to preparing for an advisory committee that maximizes your chance of success, no matter your level of experience in this challenging process.

Click Here To Register!

Top CMS Job Remains Empty Despite Big Medicare Changes On The Horizon

Full article reprinted from "The Gray Sheet" - November 30, 2009

Health care policy experts are largely resigned to waiting until health care reform legislation passes to learn who the next CMS administrator will be, but some are dismayed that 10 months into a new administration, no permanent appointee has been named to lead the world's largest and most influential health care payer. Read more...

Device Firms Want Two Years To Comply With Electronic MDR Rule

Full article reprinted from "The Gray Sheet" - November 30, 2009

Covidien, AdvaMed and the Medical Imaging and Technology Alliance are asking FDA to give device manufacturers two years to comply with an upcoming rule requiring adverse event reports to be submitted to the agency electronically. Read more...

FDA Is Expanding Transparency Efforts To Focus On Industry Questions

Full article reprinted from "The Gray Sheet" - November 16, 2009

FDA has expanded its transparency initiative to cover an area that was unanticipated, Deputy Director Joshua Sharfstein said: explaining how the agency works to the industry it regulates. Read more...