13 Matching Annotations
  1. Jan 2018
    1. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)s require clinical data to support the application.
    2. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution.

      Not sure if charging patients to participate and use an investigational device would be considered "commercial distribution".

    1. For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for. In that case, a 510k will be the route to market.
    2. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing.
    1. This is the page to learn FDA device regulation.

    2. An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to FDA.

      No matter what Class the device is, this must be applied first for the device to even be studied in a clinical trial.

    3. Product requiring PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process.

      It is important to determine if the device is Class III or not.

    4. All registration information must be verified annually between October 1st and December 31st of each year.
    5. medical devices must register their establishments with the FDA.
    6. most Class III devices require Premarket Approval
    7. Manufacturers must list their devices
    8. Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB) before the study can begin. Studies with devices of nonsignificant risk must be approved by the IRB only before the study can begin.

      Either high risk or low risk, IRB is necessary. High risk one needs FDA approval, too, for clinical study of the device.

    1. New device with no substantial equivalent but with a low risk can file an application to be classified as De Novo and request FDA to make a risk based classification.