Select the correct Premarket Submission

After the device classification, you then select the premarket submission required for that regulation. The most common types of premarket submissions include:

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. more....

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.

 

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