All posts in Regulatory
FDA Issues Draft Guidance on Device Changes That Warrant New Premarket Review
SILVER SPRING, Md., July 26, 2011 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The 510(k) process is the …
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
57 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in March
The Food and Drug Administration issued 57 orthopedic- and spine-related 510(k) clearances in March, according to an FDA report. 1. MSA Hip System from Global Manufacturing Technology. 2. Laguna Pedicle
ArthroCare Announces Settlement of SEC Investigation
ArthroCare Corp. (NASDAQ: ARTC) (the "Company") announced today that it has entered into a settlement with the United States Securities and Exchange Commission ("SEC") that fully resolves the
Judge strikes down healthcare reform law
By Tom Brown MIAMI | Mon Jan 31, 2011 4:45pm EST (Reuters) - A federal judge in Florida struck down President Barack Obama's landmark healthcare overhaul as unconstitutional on Monday, in the
Alphatec Spine, Inc. 1/11/11
WARNING LETTER VIA UPS EXPRESS JAN 11 2011 Paula Morgan, RAC Senior Director, Regulatory Affairs Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Dear Ms. Morgan: The Food and Drug Administration (FDA)
49 Orthopedic and Spine Devices Receive FDA 510 (k) Clearance in December
The Food and Drug Administration issued 49 orthopedic- and spine-related 510(k) clearances in December, according to an FDA report. 1. NuVasive Spherx II-Mas Deformity Spinal System from NuVasive. 2. Concorde
Stryker Sues Zimmer Over U.S. Wound-Treatment Device Patents
By: Susan Decker Dec. 14 (Bloomberg) -- Stryker Corp., a maker of artificial knees and hips, filed a patent-infringement lawsuit against Zimmer Holdings Inc. to block sales of a
Minnesota senators recruit buddies to pressure FDA over 510(k)
As the duly elected representatives of the great state of Minnesota, Sens. Amy Klobuchar and Al Franken along with Rep. Erik Paulsen have championed the medical device industry,
Exactech announces resolution of government investigation
Exactech, Inc., a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced in a press release that it has
10 Orthopedic and Spine Devices Recently Launched or Approved
Here are ten device companies that recently launched orthopedic products or received FDA approval for the products. 1. Integra LifeSciences' Ruggles kerrison rongeurs. The Ruggles kerrison rongeurs is a
Biomet Receives FDA Warning Letter, Seeks Resolution with FDA
WARSAW, Ind. - (Business Wire) On July 28, 2010, Biomet received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding the Signature™ Personalized Patient Care