What is Premarket Notification 510(k)?

Posted 3 months ago
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In the U.S. FDA electronic Submission Template And Resource (eSTAR) form submission in the Application Purpose, there are three options to choose:

  1. Premarket Notification 510(k)
  2. De Novo
  3. Premarket Application PMA

The 510(k) submission process allows medical device companies to get approval to sell their devices in the United States. Instead of going through the long and complicated process called premarket approval (PMA), companies can submit a 510(k) application to show that their device is similar to another device that is already legally sold in the U.S. This proves that their device is safe and effective enough to be on the market. This process is known as Premarket Notification 510(k),

 

If a company wants to sell a Class I, Class II, or Class III medical device in the U.S. and doesn't need a PMA, it must send a 510(k) premarket notification to the FDA unless the device is exempt. This 510(k) includes detailed information about the device's work and safety. The company needs to show that its device is "substantially equivalent" to a device that is already approved and sold in the U.S., known as a "predicate device."

 

The FDA reviews the 510(k) submission to decide if the new device is as safe and effective as the predicate device. The company can only sell the new device once the FDA gives its clearance, which usually takes about 90 days. During this time, the company compares its device to the predicate device and provides evidence to support its claim of substantial equivalence.

 

A predicate device can be one that was legally sold before May 28, 1976, one that has been reclassified from Class III to Class II or I, one that was approved through the 510(k) process, or one that received marketing authorization via the De Novo classification process. The predicate device must not violate any FDA rules.

 

Once the FDA determines that the new device is substantially equivalent, the company can start marketing it in the U.S. The FDA usually does not inspect the manufacturing facility before giving 510(k) clearance. Still, the company should be ready for an FDA quality inspection at any time after clearance is granted.