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Various neonatal chemistry systems and Immunoisoelectric focusing diagnostic kits manufactured by PerkinElmer Life Sciences were seized last week after the FDA repeatedly warned the company to correct numerous quality system violations at its Norton, Ohio facility where the products are manufactured.
The appropriations slump that threatened to end the device user fee program will be made up next fiscal year under President Bush’s latest budget proposal, which will allow the Center for Devices and Radiological Health (CDRH) to continue assessing fees until Oct. 1, 2007.
A return to full-scale comprehensive inspections is on the horizon for devicemakers, but the timeline for implementation depends on how fast the Center for Devices and Radiological Health (CDRH) can train third-party inspectors under the Accredited Persons (AP) program.
New White House estimates on the cost of the Medicare prescription drug plan could net manufacturers an additional $49 billion in profits, according to congressional Democrats who have demanded that price control mechanisms be added to the benefit program.
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.
Devicemakers benefit just as much as hospitals from exclusive supply contracts negotiated by group purchasing organizations (GPOs), according to a new study sponsored by the Health Industry Group Purchasing Association (HIGPA).
As more health insurance plans adopt multitiered drug copays, the widening spread between the lowest-priced generic and the highest-priced nonpreferred brand drug is boosting the fortunes of generics and presenting new threats to brands’ bottom lines, industry observers say.
The FDA is broadening the regulatory scope of its tissue products regulations to include heart valves and dura mater, which have been traditionally regulated as devices by the agency.
Devicemakers do not have to substantially revise ISO 13485-compliant quality management systems (QMS) to meet the FDA's quality system regulation (QSR) because the standard does not set up conflicting requirements, according to David Feigal, director of the Center for Devices and Radiological Health (CDRH).
The Accreditation Council for Continuing Medical Education (ACCME), a major accreditor of continuing medical education (CME) providers, said it does not intend to block physicians paid by device companies from participating in CME events.