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The EU was set to sign on as a full observer to the International Medical Device Regulators Forum’s single audit program when the group met in Tokyo in late March, according to an FDA official familiar with the talks. Read More
Devicemakers soon will start feeling the impact of the Center for Devices and Radiological Health’s inspectorate overhaul following the addition of quality-driven metrics and pre- and postapproval confirmation of controls audits, a center official says. Read More
Margaret Hamburg has resigned as commissioner of the U.S. FDA, effective at the end of this month, ending a six-year tenure that saw the agency speed up its device approval process and increase its focus on personalized medicine. Under Hamburg’s watch, the agency’s budget rose by nearly $2 billion — from $2.7 billion in fiscal year 2009 to $4.5 billion this year. Read More
The FDA has handed Cenorin a warning letter for not reporting modifications to its Medical Device Cleaning and HLD Washer/Pasteurizer Model 610. Read More
Devicemakers that market products in Canada must certify their quality systems through the International Medical Device Regulators Forum’s single-audit program, beginning in 2017, regulators say. Read More
A years-long standoff between the U.S. FDA and Maquet ended with a consent decree calling for the devicemaker to improve quality at its three subsidiaries. Read More
The China Food and Drug Administration plans to revise its device good manufacturing practices to include specific GMPs for sterile and implantable devices. The revisions, outlined in a Feb. 9 draft guidance, aim to bring GMPs for these products up to par with international standards, Seth Goldenberg, director of global regulatory strategy at NAMSA, tells GMP. Read More
TreyMed, a contract manufacturer of sensors, received a warning letter from the U.S. FDA after modifying entries in its inspection data record for parts that resulted in failures. Read More
Topspins, a specification developer and own-label distributor of IV tubing sets, was warned by the U.S. FDA after making design changes without appropriate validation. Read More
Failure to give the FDA a written report of a correction made to its Point-of-Care Unit, an infusion therapy delivery device, resulted in a Form 483 for CareFusion 303. Read More
Women’s healthcare device manufacturer CooperSurgical received a Form 483 for failure to initiate corrective action for a process failure associated with its Blunt Hurd Cannula-Blunt Tip 10mm with 5mm Reducer. Read More
Failure to adequately establish requirements that must be met by suppliers, contractors and consultants resulted in a Form 483 for Steris following a July 14 inspection. Read More