International Medical Device Regulatory Monitor

The imaging industry could be hit hard if alternative sources of molybdenum 99 (Mo-99) are not developed in the next five years.

The U.S. Food and Drug Administration (FDA) expects to release a proposed rule for a unique device identifier (UDI) database this summer and is aiming at having a final rule in place by April 2011.

Devicemakers may have to pay up to 40 percent more to test the safety and effectiveness of electronic devices once countries adopt an international standard for the products.

Devicemakers are concerned that a May 24 deadline for good manufacturing practice (GMP) inspections of facilities seeking to register or reregister in Brazil could cause major disruptions in supplies to the Brazilian market.

As the International Organization for Standardization (ISO) and the U.S. Food and Drug Administration (FDA) seek to tighten the accuracy standard for blood glucose meters used by diabetics, industry says a stricter standard would result in trade-offs without solving all the problems.

“Standards” will become the new watchword at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) as the center seeks regulatory alternatives to guidances and advisory panels and strives for more consistency in its processes.

Although the latest revision to the EU’s Medical Device Directives (MDD) just went into effect last month, devicemakers may be expected to transition to another recast within five years.

The U.S. Food and Drug Administration (FDA) is continuing to monitor titanium alloy imported from China and encouraging manufacturers to remain vigilant in their supplier controls.

Makers of CE-Marked cardiac ablation catheters (CACs) should have procedures in place for the ongoing postmarket review of their products, according to a draft guidance by the Medicines and Healthcare products Regulatory Agency (MHRA). Includes the full text of MHRA Draft Guidance on CAC Postmarket Vigilance.

Devicemakers are taking issue with a proposed U.S. rule that would restrict the shipment of lithium batteries in airplanes, saying it could cost them millions of dollars and lead to cutbacks in expansion, innovation and R&D. Includes full text of US Transportation Department Rule on Shipping Lithium Batteries.

The device industry is concerned that a new decree in Italy requiring the disclosure of latex in devices could catch on across the EU, creating an added burden for manufacturers.

Sponsors seeking a humanitarian device exemption, premarket approval or a product development protocol in the U.S. for a device intended to treat adults will have to provide information about possible pediatric populations, according to a new rule. Includes the full text of US FDA Rule on Pediatric Data.

Devicemakers are now required to get approval from the Federal Institute for Drugs and Medical Devices (BfArM) and an ethics committee before beginning clinical trials in Germany.

China’s State Food and Drug Administration (SFDA) has inaugurated a new center aimed at standardizing and streamlining the country’s medical device standards process.

A U.S. court in New York has ruled that certain claims of patents on Myriad Genetics’ breast and ovarian cancer screening system BRACAnalysis are invalid, a ruling that is expected to have a negative effect on innovation in the diagnostic industry.

French company Poly Implant Prothese (PIP) has suspended operations and is recalling its silicone gel breast implants after an investigation revealed the company has been using an unapproved gel.