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Topic: Dr. Jeffrey Shuren

Mobile medical apps to be topic of FDA workshop on agency’s guidance

Mobile medical apps to be topic of FDA workshop on agency’s guidance

August 18, 2011 2:25 pm by | 0 Comments

The FDA planned a public workshop for mid-September to discuss the recently released draft guidance regarding regulation for mobile medical apps.The guidance includes a fairly narrow subset of medical apps, ... Read more
Benefit-risk determination for premarket applications outlined by FDA

Benefit-risk determination for premarket applications outlined by FDA

August 16, 2011 4:15 pm by | 0 Comments

The FDA released a new guidance yesterday detailing the agency’s process of making benefit-risk determinations when assessing premarket applications for medical devices for “reasonable assurance of safety and effectiveness.”The agency ... Read more
FDA guidance on clinical trials aims to help device makers

FDA guidance on clinical trials aims to help device makers

August 16, 2011 12:11 pm by | 0 Comments

The FDA took bold steps to outline expectations for medical device premarket submissions in the release of a new draft guidance that outlines the basic structure for clinical trials.The document ... Read more
Shuren to MN device industry: Reviewers will undergo training

Shuren to MN device industry: Reviewers will undergo training

August 3, 2011 2:03 pm by | 4 Comments

One long-running complaint, among the litany of complaints, about the U.S. Food and Drug Administration revolves around reviewers at the Center for Devices and Radiological Health.Some say when reviewers change, ... Read more
FDA, Minnesota device industry to collaborate on regulatory science

FDA, Minnesota device industry to collaborate on regulatory science

August 3, 2011 12:36 pm by | 1 Comments

How can there be speedy, early assessments of new innovative medical devices?The U.S. Food and Drug Administration and the Minnesota medical device community may have hit upon an answer.At the ... Read more
IOM’s 510(k) assessment says FDA should abandon the entire process

IOM’s 510(k) assessment says FDA should abandon the entire process

July 29, 2011 11:03 am by | 0 Comments

The U.S. Food and Drug Administration’s certification of medical devices lacks the legal framework to be a “reliable premarket screen” and should be scrapped, according to the Institute of Medicine’s ... Read more
FDA’s Shuren: No retaliation against companies who criticize FDA

FDA’s Shuren: No retaliation against companies who criticize FDA

June 15, 2011 5:27 pm by | 0 Comments

There will be no retaliation against companies who tell the U.S. Food and Drug Administration that its processes are too burdensome and unpredictable.Those are the words of Jeffrey Shuren, director ... Read more
FDA’s Shuren says new 510(k) survey is informative, but limited in scope

FDA’s Shuren says new 510(k) survey is informative, but limited in scope

May 24, 2011 4:23 pm by | 0 Comments

A new survey critical of the U.S. Food and Drug Administration’s 510(k) review process makes important suggestions for improvement, but is not representative of the industry as a whole.That was ... Read more
New appointment of FDA official unsettles medical device industry

New appointment of FDA official unsettles medical device industry

August 10, 2010 5:21 pm by | 0 Comments

Since he assumed his post in January, Dr. Jeffrey Shuren, the top Food and Drug Administration official on medical devices, has walked a delicate tightrope.He has worked hard to reassure ... Read more
Data suggests orthodpedic firms should worry most about FDA changes

Data suggests orthodpedic firms should worry most about FDA changes

July 7, 2010 4:48 pm by | 0 Comments

Minnesota’s medical device companies have openly fretted about the Food and Drug Administration altering or even eliminating the popular 510(k) clearance program.From venture capitalists and entrepreneurs to doctors and academics, ... Read more
Protecting innovation in medical technology

Protecting innovation in medical technology

July 7, 2010 8:54 am by | 0 Comments (Sponsored)

At a time when medical device companies are facing challenges like the $20 Billion excise tax (part of national health care reform), there is industry-wide concern that FDA will increase ... Read more
A note on the Med Tech Investment conference in Minneapolis

A note on the Med Tech Investment conference in Minneapolis

May 21, 2010 5:00 am by | 0 Comments

As a journalist, I’m frequently beset with impulsive self-righteousness. Which is why I jumped the gun a bit this week.I wanted to attend the Med Tech Investment conference in Minneapolis ... Read more
Is there a patient in the room? Please present yourself to the FDA

Is there a patient in the room? Please present yourself to the FDA

May 18, 2010 4:00 pm by | 2 Comments

“This is all about patients,” Dr. Susan Alpert, Medtronic Inc.’s top regulatory officer, told Food and Drug Administration officials Tuesday at a town hall meeting in Bloomington, Minnesota.But was it? ... Read more