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The Centers for Medicare & Medicaid Services is broadening the scope of its prior authorization program for power mobility devices, expanding it geographically. The program determines whether items meet Medicare coverage requirements before they reach beneficiaries. Read More
The South Korean government is proposing strict quality controls to ensure the safety of unregistered devices distributed during public health emergencies. Read More
Abbott’s efforts to work with the Centers for Medicare & Medicaid Services to improve reimbursement for its MitraClip transcatheter mitral valve repair system have paid off with an advisory panel’s recommendation to cover the procedure. Read More
Argentina’s ANMAT has adopted strict traceability requirements for medical devices, with the aim of stemming the flow of counterfeit products. Read More
As 3D printing gains popularity among medical devicemakers, the FDA wants to get advice from manufacturers and researchers to guide its product reviews and possibly future guidance. Read More
Sen. Patrick Leahey (D-Vt.) effectively killed any chance at patent reform legislation last week by removing H.R. 1720 from the agenda of the Senate Finance Committee, which he chairs. Read More
Senate lawmakers want to give the FDA $2.588 billion in discretionary funds in the next fiscal year, a $36 million boost over current levels and $13 million more than is provided in a related House bill. Read More
Only devices that violate the 1938 FD&C Act should be labeled Import for Export, FDA officials cautioned at the recent FDA/Xavier University MedCon conference. Read More
All devicemakers holding CE certificates for Class IIa medical devices and higher should be prepared for unannounced quality system visits by notified body inspectors. Read More
As the clock ticks down for high-risk devices to comply with the FDA’s unique device identifier rule, the first organization accredited to issue UDIs is offering devicemakers some advice. Read More