Guidance, Standards, and Regulation

With the FDA’s new regulation enforcement of laboratory developed tests (LDTs) beginning May 6, 2025, laboratories across the country are…

While many laboratories are understandably concerned about the FDA’s new laboratory developed test (LDT) regulations, and there is much uncertainty…

  So, you have a medical device that you are ready to put on the market? You’ve identified a product…

  When trying to determine FDA medical device classification, there are a few ways to get information and feedback from…

  Changes to  FDA recognized consensus standards this year may catch many medical device manufacturers off-guard when preparing their medical…

  In June of 2022 the FDA issued an updated guidance for “Electromagnetic Compatibility (EMC) of Medical Devices”.  This guidance…

  The FDA has identified a list of Class I and Class II medical devices that are exempt from 510(k)…