FDA Approvals - FDA Has Reduced Enforcement Of Standards For Medical Device Laboratories,
FDA Has Reduced Enforcement Of Standards For Medical Device Laboratories, Report Finds (Medical News Today)
The Center for Devices and Radiological Health at FDA in recent years has reduced enforcement of "good laboratory practices" for facilities that develop medical devices, according to a report released on Wednesday by the Project on Government Oversight, the AP/Kansas City Star reports.
Cardinal Health 303, Inc. Signs Amended Consent Decree With FDA (Medical News Today)
The U.S. Food and Drug Administration announced that California device manufacturer Cardinal Health 303 Inc., formerly known as Alaris Medical Systems Inc., and three of its top executives have signed an amended consent decree to correct violations of current Good Manufacturing Practice (cGMP) requirements in the company's infusion pumps.
Revolutions Medical Receives 510K FDA Clearance To Market Rev Vac Safety Syringe (Medical News Today)
Revolutions Medical Corporation (OTCBB: RMCP) has received notification from the FDA that the 510K application for the Rev Vac safety syringe is approved. This represents a major step forward for the company towards realizing its goal in becoming a major player in the safety syringe market.