Routes to Market Access in the US

Medical devices in the US are classified by the Food and Drug Administration (FDA) into three classes: Class I being the lowest risk and Class III the highest risk. More details can be found in the Code of Federal Regulations (21 CFR, Parts 800-1107).

  • 510(k) or Pre-Market Notification
    This is the primary mechanism. This notification is made under section 510(k) of the Federal Food, Drug and Cosmetic Act. Its purpose is to demonstrate to the FDA that the ‘new’ device is “substantially equivalent” to another that was on the market prior to May 28, 1976 or a device that has already been accepted through the 510(k) process.
  • IDE or Investigational Device Exemption
    New significant risk devices cannot be tested in human subjects without prior permission from the FDA and an Institutional Review Board (IRB). The application filed for this approval is called an Investigational Device Exemption (IDE). 
  • PMA or Pre-Market Approval
    The formal approval of the FDA of the safety and effectiveness of the medical device based on valid device-related scientific data and rationale. This process mostly applies to Class III medical devices with the most novel and complex technologies; documentation requirements are substantially greater than for a 510(k) and the PMA applications are subject to rigorous scrutiny by the FDA. 
  • De Novo process
    In the US, medical device manufacturers whose products pose low to moderate risks but have no identifiable predicate devices are classified as Class III by the FDA. The FDA De Novo process is designed for “novel” medical devices for which manufacturers cannot establish substantial equivalence, but whose risk profiles do not necessarily warrant Class III designation. There are two De Novo process pathways in order to obtain a reclassification of your novel device. The first option is the pre De Novo submission (PDS), the second is a standard 510(k) submission resulting in a not substantially equivalent (NSE) decision by FDA.

All medical devices have to be listed with the FDA (Medical Device Listing) and all companies intending to market their medical devices in the US must notify the FDA of their intention and be registered (Establishment Registration), prior to the introduction of their products into the US market.

Regardless of the product classification, Quality Systems Regulations (QSR) compliance is almost always required. Companies that do not have a US mailing address also must designate a US Agent to serve as their intermediary with the US FDA.

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