A lawsuit that charges the FDA with monitoring the personal email of former CDRH employees has sparked a congressional probe and prompted fears among legal experts, who say the FDA’s actions could have a chilling effect on other whistleblowers.

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Fired FDAers Sue for Email Monitoring: Senator Moves for Probe of FDA

Hospitals may be overpaying for implantable medical devices and passing those costs on to Medicare, but it is impossible to know for certain because Medicare doesn’t track device prices or what hospitals pay for them, a Government Accountability Office (GAO) report concludes.

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GAO: Lack of Transparency in Hospital Device Purchasing

Rather than breaking device user fees out of an omnibus bill, House Energy & Commerce Health Subcommittee Chair Joe Pitts (R-Pa.) reportedly has threatened to freeze device fees at current levels for five years if the FDA and industry can’t speed up an agreement on Medical Device User Fee Act (MDUFA) reauthorization.

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Delays in MDUFA Agreement Threaten Omnibus User Fee Bill

A compromise reached by the FDA and device industry on medical device user fee reauthorization should benefit both parties and speed patient access to innovative technologies, AdvaMed President Stephen Ubl said.

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AdvaMed: MDUFA Agreement Could Be “Game Changer” for FDA, Industry

X-FAB Silicon Foundries, a manufacturer of wafers for medical industry, has utilized Silicon Frontline Technology’s (SFT) Resistive 3D ( R3D) software for its 0.18 micrometer high-voltage process (XH018) to provide improvements in reliability and efficiency.

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X-FAB adopts SFT R3D software