Jul 29, 2020
The US Food and Drug Administration (FDA) published a final order listing categories of Class II medical devices that are now exempt from 510(k) premarket notification. The order also establishes new product codes and changes the title associated with one existing product code.
Background of FDA exemptions under the 21st Century Cures Act
In 2016, the 21st Century Cures Act required that the FDA publish lists of medical devices to be exempt from 510(k) notification at least once every five years. This provision was intended to streamline the regulatory system by reducing the agency’s workload along with costs to device manufacturers. When the first round of exemptions were announced in 2017, we reported on the Class I and Class II devices that were exempted from 510(k) requirements.
While this new list of Class II device exemptions is less sweeping than the initial round, it takes place well before the mandated five-year deadline. The final order was published in the Federal Register on July 22 and became effective immediately.
List of exempted device categories with limitations
The FDA order lists five categories of medical devices that are henceforth exempt from 510(k) premarket notification requirements, but four out of five of the categories come with designated limitations to the exemptions. Since these device types are now split into exempt and non-exempt groups, the FDA introduced new product codes to differentiate the exempt devices. The table below, which is based on the table published in the FDA order, illustrates the changes:
|
Device type |
Corresponding section of 21 CFR (Code of Federal Regulations) |
Limitation to exemption |
Non-exempt product code (existing) |
Exempt product code (new) |
|
Accessory, Assisted Reproduction |
884.6120 |
Limited to assisted reproduction laminar flow workstations |
MQG |
QKH |
|
Media, Reproductive |
884.6180 |
Limited to phosphate-buffered saline used for washing and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications |
MQL |
QKI |
|
Instruments Designed for Press-Fit Osteochondral Implants |
888.4505 |
Not limited |
QBO |
Not applicable; all QBO devices exempt |
|
Interactive Rehabilitation Exercise Devices |
890.5360 |
Limited to prescription-use only |
LXJ |
QKC |
|
Massager, Therapeutic, to Internally Massage Trigger Points in the Pelvic Floor Musculature |
890.5670 |
Limited to prescription-use only devices that use a quantitative feedback mechanism and a disposable covering |
OSD |
QKD |
FDA updates title of devices associated with product codes LXJ/QKC
Previously, the product code LXJ was applied to a device type listed as “System, Optical Position/Movement Recording.” Because this description no longer encompasses the full scope of devices identified by its product code, the order changes it to the more accurate “Interactive Rehabilitation Exercise Devices.” This description is also to be used for the exempt devices now designated under product code QKC.
Related US FDA medical device and IVD regulatory resources:
- US FDA QSR quality management system (21 CFR Part 820) compliance consulting
- US FDA 510(k) registration consulting for medical device and IVD companies
- FDA submission consulting for medical devices and IVDs
- RAMS Smart Builder for 510(k) submissions
- Whitepaper: Preparing a US FDA 510(k) submission
Author
- Timothy Herr