Article: A checklist for using home-based medical devices.(fda.gov)(Brief Article)

Article: FDA Issues Public Health Notification on Phthalates in ...
PR Newswire;  July 15, 2002 ;     700+ words ... ... softener used in medical devices made of polyvinyl chloride (PVC). The FDA document said that ... However, the FDA failed to require ... DEHP-containing medical devices, leaving health ... products. "The FDA's notification about phthalates in medical devices not only ...

Article: FDA seeking comments on use of identifier system for ...
M2 Presswire;  August 10, 2006 ;     700+ words ... ... 2006-US FDA: FDA seeking comments ... identifier system for medical devices identifier system ... and complexity of medical devices is growing. It is important for FDA to quickly identify ... distribution and use of medical devices. FDA also commissioned ...

Article: FDA SEEKING COMMENTS ON USE OF IDENTIFIER SYSTEM FOR ...
US Fed News Service, Including US State News;  August 9, 2006 ;     700+ words ... ... Administration (FDA) is seeking information ... identifier system for medical devices may reduce medical ... and complexity of medical devices is growing. It is important for FDA to quickly identify ... distribution and use of medical devices. FDA also commissioned ...

Article: Senate Votes to Speed FDA Approval Process for Drugs, ...
The Washington Post;  September 25, 1997 ;     700+ words ... ... would prevent the FDA from testing medical devices, such as biopsy ... labeling and use of medical devices, the bill would ... already underway at FDA that are designed ... according to the FDA. For high-risk medical devices, agency officials ...

Article: FDA TAKES THREE TIMES LONGER THAN EUROPEAN COUNTERPARTS TO ...
PR Newswire;  February 20, 1996 ;     700+ words ... ... approval of new medical devices. As Congress ... Administration (FDA), patients ... died." The FDA already takes ... breakthrough medical devices as is allowed ... improvement at the FDA." American manufacturers of medical devices say the unnecessary ...

Article: FDA Issues Order Requiring Safety And Effectiveness ...
Mondaq Business Briefing;  May 15, 2009 ;     700+ words ... ... Amendments of 1976, the FDA classifies medical devices into three regulatory ... Congress directed FDA in the Safe Medical Devices Act of 1990, Pub ... 1976 types of medical devices that were identified ... been subject to FDA premarket approval ...

Medical Devices: Challenges for FDA in Conducting ...
General Accounting Office Reports & Testimony;  March 1, 2008 ;     700+ words ... ... Administration's (FDA) oversight of the ... effectiveness of medical devices marketed in the ... participation. (Medical Devices: Status of FDA's Program for ... establishments manufacturing medical devices that FDA has classified as ...