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The future of the FDA’s Center for Devices and Radiological Health (CDRH) will be focused on meeting the goals established by the Medical Device User Fee and Modernization Act (MDUFAMA), said the center’s new acting director Dan Schultz
The FDA has issued a detention order for all transcutaneous electrical nerve stimulator (TENS) devices and acupuncture needles shipped by a Canadian repackaging firm cited for failure to maintain adequate quality systems (QS) and medical device reporting (MDR) procedures.
Devices and diagnostics companies need to design highly effective risk management systems to avoid becoming the next target for liability attorneys searching for the next landmark liability tort, said Kevin Quinley, senior vice president of risk services at Medmarc Insurance Group.
Devices and diagnostics manufacturers must develop effective strategies for managing FDA site inspections to avoid common pitfalls that lead to strict regulatory enforcement actions, said compliance experts Russ Davies and Donald Segal.
Johnson & Johnson subsidiary Cordis has been cited by the FDA for a series of current good manufacturing practice violations stemming from a postapproval inspection at five sites that produce the Cypher drug-eluting stent.
The FDA concluded its inspection of Utah Medical Products (UTMD) on March 3 by issuing the company a Form 483 citing seven violations of the agency’s quality system regulation (QSR).
Utah Medical Products (UTMP) has filed a lawsuit against the FDA to prevent the agency from conducting wasteful inspections at its Medvale, Utah, manufacturing plant.
Devicemakers undergoing a preapproval inspection should form a team that includes a coordinator, runners, scribes and subject experts to ensure that FDA inspectors’ needs are being met and that the scope of the inspection does not go beyond the agency’s authority.
The FDA is giving a dental laboratory in Costa Rica a final chance to correct several quality system violations cited during a recent inspection before taking further regulatory action.