June 2012 | Full Issue in PDF Format
CDRH officials plan a series of public forums in 2012 to gather data to develop an implementation plan for the center’s Case for Quality Initiative — which aims to create an ongoing culture of quality at medical device manufacturers.
The Office of Management and Budget (OMB) could release the FDA’s proposed rule on a unique device identification (UDI) system “any day now,” an agency official says, ending a nearly year-long delay in finalizing the much-anticipated safety mechanism.
China is expected to begin amending its current medical device rules this year, as part of its 12th five-year plan to update its drug and device regulations, according to a panel of China experts at the Food and Drug Law Institute’s annual conference in Washington, D.C.
CINCINNATI — Companies who react to a warning letter simply by fixing the immediate problems may put themselves at risk for future incidents, experts said last month at the FDA/Xavier University MedCon Conference.
Branan Medical, a maker of drug testing kits, received an FDA closeout letter resolving myriad marketing clearance and manufacturing concerns cited in a 2009 warning letter.
Prosec Protection Systems, a maker of umbilical clamps, received a Form 483 for various process validation deviations at its Lakewood, N.J., plant.
Shortcomings related to color coating processes and controls for Stingray Surgical Product’s forceps and other devices landed a Form 483 for the Florida-based company.
A review of several corrective and preventive action (CAPA) forms at Aqueduct Medical’s San Francisco facility revealed inadequate CAPA validation and follow-up, a recent Form 483 states.
Amplivox, a UK subsidiary of Danish company William Demant, received a warning letter from the FDA following a December inspection of its Oxford manufacturing plant.
Cross-border sharing of devicemaker audit results should be easier thanks to a standardized nonconformity grading system developed by the Global Harmonization Task Force’s (GHTF) Study Group 3.
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