Types of 510(k): Traditional, Special and Abbreviated

The US Food and Drug Administration has three types of 510(k) Premarket Notification applications:

TRADITIONAL 510(k) submission – Most companies introducing a new Class 2 medical device must submit a traditional 510(k) Premarket Notification. This is a full 510(k) that includes all 21 sections. Read more about the sections and format of a Traditional 510(k).

ABBREVIATED 510(k) submission – When you submit an Abbreviated 510(k), you are providing summary reports that demonstrate your use of guidance documents, special controls or Declarations of Conformity to recognized standards to expedite review of your submission. You might qualify to submit an Abbreviated 510(k) if:

• FDA Guidance document(s) exists
• Special controls have been established
• The FDA has published a recognized Consensus Standard that you have followed

SPECIAL 510(k) submission- The final type of FDA Premarket Notification is called the Special 510(k). This is used when a modification has been made to a medical device that already has 510(k) clearance. It allows the manufacturer to declare conformity with the Design Controls set out of 21 CFR Part 820 without providing the data. The special 510(k) also applies to Preamendment Devices (those approved before May 28, 1976).

Contact us to request a proposal or consultation about which type of 510(k) submission is most appropriate for your medical device.