Medical Devices/Equipment DME Durable Medical Equipment
New Critical Path Report Highlights Research Needed to Foster Generic Drug Development
The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product
Date:
05/02/2007
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01626.html
FDA Requests Recall of All Shelhigh Medical Devices
at FDA's request, seized all medical devices including components at Shelhigh's Union, N.J. facility after finding significant deficiencies in the company's manufacturing processes.
Date:
05/02/2007
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01625.html
FDA Announces Recommendations to Reauthorize Medical Device User Fee Program
...which, if adopted, would help to ensure that safe and effective medical devices get to patients in a timely manner.
Date:
04/16/2007
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01609.html
FDA Provides Web Access to Information on Post-Approval Device Studies
Modern devices provide significant health benefits, but experience has shown that the full magnitude of some potential risks doesn't always emerge during the mandatory clinical trials that are required for approval
Date:
04/06/2007
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01603.html
Latebreakers: DMEPOS Web site goes live
Durable medical equiment, prosthetics, orthotics, and supplies bidding site
Date:
04/02/2007
, Publication:
Drug Topics
, Author:
Drug Topics
http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=415065
New Technology Heralds Hope
Breakthrough therapies and technologies provide the tools to improve muscle disorders with gait and balance training.
Date:
04/01/2007
, Publication:
Rehab Management
, Author:
Susan Golden, PT
http://www.rehabpub.com/issues/articles/2007-04_02.asp
Not a Lightweight Decision
Selecting an ultralight wheelchair: Six common mistakes, and how to fix them
Date:
04/01/2007
, Publication:
Rehab Management
, Author:
Ginny Paleg, MS, PT
http://www.rehabpub.com/issues/articles/2007-04_04.asp
Yearly breast MRIs urged for 1.4 million women
New cancer guidelines advise pricey screening for those at high risk
Date:
03/29/2007
, Publication:
MSNBC
, Author:
Associated Press
http://www.msnbc.msn.com/id/17818068/
Medical Devices 101: An Educational Forum; Public Workshop
This public workshop is intended to provide an overview on FDA's medical device requirements to entrepreneurs, startup companies, and small businesses.
Date:
01/09/2007
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/OHRMS/DOCKETS/98fr/07-92.htm
CMS names 11 accreditors for DMEPOS suppliers
The Centers for Medicare & Medicaid Services recently selected 11 national organizations to accredit suppliers of durable medical equipment, prosthetics, orthotics, and supplies...
Date:
01/08/2007
, Publication:
Drug Topics
, Author:
Sandra Levy
http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=394814
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