By Eric Thorn, Esq.
Well to start off with, no a 510(k) is not some type of retirement plan, that’s a 401(k). Section 510(k) is a section of the Food, Drug and Cosmetic Act (FD&C Act) that requires device manufacturers to provide the Food and Drug Administration (FDA) with at least 90-day advance notice of their intent to market certain medical devices.
This advance notice is known as a Premarket Notification or a 510(k) submission. Once the FDA receives notification the FDA begins the process to determine whether the device is the equivalent of a device that has already been classified in one of the three device classification categories.
Not all devices require 510(k) pre-market clearance. Some devices are 510(k) exempt. For example, Preformed Crowns (ELZ), Preformed Plastic Denture Teeth (ELM) and Orthodontic Wire (DZC) are 510(k) exempt. Some examples of devices that do require 510(k) clearance include; Implant Abutments (NHA), Antisnoring Devices (LRK), Intraoral Jaw Repositioning Devices for Snoring (LQZ) and Zirconia Discs used to make crowns (EIH).
The purpose of the 510(k) submission is to demonstrate to the FDA that the device to be marketed is substantially equivalent and thus is as safe and effective as another legally marketed device (See FDA.gov-What is Substantial Equivalence). The device(s) to which equivalence is drawn is referred to as the “predicate” device.
The 510(k) submission is a device manufacturer’s opportunity to compare their device to one or more similar devices already on the market in support of the claim that their device is substantially equivalent to a predicate device that was legally marketed prior to May 28, 1976 (pre-amendments device), or substantially equivalent to a predicate device that the FDA has already cleared to be marketed since then through the FDA’s De Novo classification process. (See Section 513(f)(2) FD&C Act).
Until the device manufacturer that made the 510(k) submission receives a substantial equivalence letter, the submitter may not proceed to market the device. The substantial equivalence determination is usually made within 90 days based on the information submitted. The device may be marketed immediately after 510(k) clearance has been granted.
So for devices that require FDA 510(k) submission, having gone through the clearance process provides dentists some assurance that those devices are safe for use by their patients.
For those who would like a little more in-depth reading regarding the 510(K) process the following links provide some additional information on the 510(k) submission process:
- Deciding When to Submit a 510(k) for a Change to an Existing Device – Guidance for Industry and Food and Drug Administration Staff (PDF – 1MB)
- Required Submission of Safety and Effectiveness Information for Certain Class III Devices
- The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications – Final Guidance
- Premarket Notification 510(k)