How Device Approval Might Be Improved

March 24, 2014 9:20 PM

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How Device Approval Might Be Improved

To boost safety and effectiveness, some changes could be made to the premarket approval supplement pathway through which some high-risk medical devices are cleared for use, according to a commentary in Annals of Internal Medicine.

Although first-generation versions of high-risk devices, such as pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices, require proof of safety and effectiveness through the premarket approval (PMA) process before going on the market, subsequ...

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