- Reprocessing OK, says FDA. // Materials Management in Health Care;Nov98, Vol. 7 Issue 11, p9
Cites the United States Food and Drug Administration's (FDA) approval of the third-party reprocessing of medical devices. Regulations that third-party reprocessors must comply with; Subjection of firms to FDA inspection and enforcement actions.
- Jurors raise a red flag for glove-makers. Rose, Joan R.; Perry, Kristie // Medical Economics;05/11/98, Vol. 75 Issue 9, p37
States that the United States Food and Drug Administration (FDA) has issued a rule which require manufacturers of medical devices containing rubber latex to include information on the label, along with the dangers associated with the wearing of the gloves. Number of reports of allergic and...
- FDA pulls rule for pediatric data. // Medical Device Daily;7/26/2010, Vol. 14 Issue 143, p8
This article focuses on the plan of the U.S. Food and Drug Administration (FDA) to withdraw the requirement that device application filings include information on the applicability of those devices to pediatric populations.
- FDA works to improve postmarket program for medical devices. // Healthcare Purchasing News;Dec2006, Vol. 30 Issue 12, p6
The article reports on the action plan by the U.S. Food and Drug Administration for strengthening the way it monitors the safety of medical device after they reach the marketplace. The action plan was developed by a Postmarket Transformation Leadership Team. It includes such items as creating a...
- New safety standard for device electric wires. // FDA Consumer;Sep/Oct97, Vol. 31 Issue 6, p2
Proposes a safety standard from the US Food and Drug Administration for manufacturers to protect the electric wires connecting patients to a medical device. Accidents caused by unprotected wires; Ten highest-risk devices.
- How To Get The Data? Scrutiny Of Postmarketing Surveillance At The FDA. // Health Affairs;Jul/Aug2005, Vol. 24 Issue 4, p927
This article focuses on the scrutiny of postmarketing surveillance at the U.S. Food and Drug Administration (FDA). The core mission of the FDA is to ensure that the drugs and therapeutic devices, which are being approved, are safe. Recent events in the wake of Merck's withdrawal of Vioxx and the...
- Complaint handling still an issue for some device firms. McCARTY, MARK // Medical Device Daily;10/30/2008, Vol. 12 Issue 212, p2
This article focuses on the warning letter issued by the U.S. Food and Drug Administration (FDA) to AliMed, a medical accessories manufacturer, for a number of deficiencies in the company's tracking and handling of complaints, as well as failures to report adverse events as medical device...
- Monitoring Medical Products Strategy. // Bioworld Week;6/23/2008, Vol. 16 Issue 25, p2
The article reports on the plan of the Food and Drug Administration (FDA) to implement its congressional mandate to develop a national active surveillance network for monitoring medical products in the U.S. It is stated that the FDA must first ensure that the privacy of patients will not...
- Failed oversight. // CMAJ: Canadian Medical Association Journal;3/31/2009, Vol. 180 Issue 7, p709
The article reports on the study conducted by the U.S. Government Accountability Office (GAO) on the U.S. Food and Drug Administration's (FDA) process for approving high-risk class III medical devices. The report states that the FDA's process is outdated, and fails to ensure the safety and...