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Regulatory Services

Marketing Approvals

  • 510(k)

    A 510(k) is a submission to the FDA to demonstrate that the device to be marketed is substantially equivalent in terms of safety and effectiveness to a legally marketed device. This is also known as “premarket notification.”

    Over the years, MED personnel have written or advised on dozens of 510(k) submissions in a wide variety of product areas.

  • PMA (Premarket Approval)

    A PMA application demonstrates the safety and effectiveness of a Class III medical device to the FDA.

    MED Institute has supported over a dozen approved PMAs with strategy development, submission writing, communication with the FDA, and advisory panel meeting support and management.

  • HDE (Humanitarian Device Exemption)

    This marketing application is similar to a premarket approval (PMA) application, but it doesn’t require a demonstration of the device’s effectiveness.

    In the early ‘80s, MED Institute helped write the legislation for HDE regulation and helped a Cook Medical product receive the first HDE ever approved by the FDA.

  • NDA (New Drug Application)

    An NDA is an application to FDA demonstrating the safety and effectiveness of a new drug.

  • CER (Clinical Evaluation Report)

    A CER is used to verify the clinical safety and performance of a medical device. A critical component of the regulatory process in the EU, it includes an assessment and analysis of clinical literature pertaining to the device, or similar devices. MED has written or assisted with over 100 CERs.

  • Shonin

    Shonin is a Japanese pre-market approval application that is submitted to the PMDA for higher-risk medical devices.

  • Ninsho

    Ninsho is a pre-market certification application submitted to a registered certification body for marketing of a controlled medical device (Class II) in Japan.