All posts in Regulatory
DuVal and Associates – CLIENT ALERT 1/2012
In this CLIENT ALERT we offer you a four part series (contained in one document) covering our thoughts on the current 510(k) and pre-IDE programs. We provide some practical insights on what it is like to approach FDA today ...
The Future of Healthcare Documentation
When President Obama revealed his dream for a national EMR/EHR system in his 2008 inaugural address, our nation's healthcare providers were given notice that current industry paradigms were
Clear as Mud: Obtaining & Marketing your 510(K) with Today’s FDA
Knowing how to get your application through FDA quickly can save millions of dollars in unnecessary investment burn. Mr. DuVal, a national authority on the 510(k) program is
The Optimization Process of Electronic Health Records
Optimization of your selected EHR system is key to healthy ROI and maximizing its potential benefits; however, it can take months for practices to develop a good, working
26 Spine Devices Receive FDA 510(k) Clearance in December Featured
The Food and Drug Administration granted 26 spine-related 510(k) clearances in December, according to an FDA report. 1. Acculif TL-PEEK IBF Cage from Coalign Innovations. 2. Renaissance System from Mazor Robotics. 3.
Senate passes bill delaying Medicare physician payment cut for 2 months
The U.S. Senate passed an amended version of a bill Saturday that postpones a 27.4% Medicarephysician payment decrease scheduled to occur on Jan. 1. The amended measure delays the
Bill Would Require More Monitoring of Implants
Amid growing problems with artificial hips and other medical implants, bipartisan legislation was introduced in the Senate on Wednesday that would force manufacturers to track the performance of
4 Insurers Will Supply Health Data
Several major health insurers have agreed to provide their claims data on a regular basis to academic researchers, in an unusual agreement that they say will open a
Floyd named CEO of Warsaw-based Orthoworx
The former worldwide president of DePuy Orthopaedics, David K Floyd, is joining the Warsaw, Indiana-based OrthoWorx as its chief executive officer effective September 6, 2011, according to a
IOM Calls 510(k) Process “Flawed”, Recommends FDA Develop New System
The long-awaited IOM report on the 510(k) framework was released this morning, and, not unexpectedly, the IOM found flaws in the system. Less expected was the recommendation that the
FDA Issues Draft Guidance on Device Changes That Warrant New Premarket Review
SILVER SPRING, Md., July 26, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device
Stuart Smalley to Med Device Community “You’re Good Enough, You’re Smart Enough…”
Sen. Franken to Top FDA Official: Seek Medical Device Community’s Expertise Before Changing Approval Process for New Products WASHINGTON, D.C. [06/23/11] – U.S. Sen. Al Franken (D-Minn.) on Tuesday
Medical device review took the FDA 37% longer in 2010 than 2006
MASSDEVICE ON CALL — Medical device consulting firm Emergo Group released results from a study of the U.S. Food & Drug Administration's medical device application review, finding that
Yeah, Sure… Like We Are Going To Believe That
FDA device chief Shuren: Recession played a role in pushing medical device industry to EU
Dr. Jeffrey Shuren tells a U.S. House panel that the recession created a more
Let The Games Begin
The Martin Memorial Health Systems in the State of Florida issued a memorandum dated May 6th, 2011 to all of its providers of medical devices and supplies. The