• Laboratory-Developed Tests and the New Administration

    Medical Device Compliance by on January 18th, 2017

    On the heels of the recent U.S. Food and Drug Administration (FDA) announcement to hold off on finalizing its oversight policy for laboratory-developed tests (LDTs), clinical laboratories developing laboratory tests will be able to enjoy the benefits of their regulatory gray zone a bit longer. For how long is unknown since the FDA remains committed […]

  • Leveraging Patient Preferences and Patient Communications in Device Promotion

    Medical Device Compliance by on November 23rd, 2016

    As the U.S. Food and Drug Administration (FDA) increasingly focuses on patient engagement in its product design and premarket review processes, a recent FDA guidance1 document outlines how device companies can utilize patient preference information (PPI) in premarket submissions for inclusion in device labeling. The guidance is limited in scope to companies submitting premarket approval […]

  • Medical Device Promotion: The Same Rules of the Road as Rx Drugs?

    Medical Device Compliance by on August 23rd, 2016

    Many pharmaceutical companies today are crossing over into the medical device world in one way or another, most frequently with diagnostics used to identify appropriate patients for particular pharmaceuticals, auto-injector devices used to administer their drugs or certain mobile apps, or software designed to aid patients or doctors. Whatever the path taken, once a company […]

  • Bringing a Medical Device to Market

    Medical Device Compliance by on February 17th, 2016

    Pipeline products are the lifeblood not only of established device companies but also of startup companies, as their future success hinges on their ability to successfully move products out of the development stage and into commercial distribution and market acceptance. While the U.S. Food and Drug Administration (FDA) prohibits the commercialization of investigational medical devices […]

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