US: FDA exempts additional Class II devices from 510(k) requirements
The FDA ordered the exemption five types of Class II medical devices from 510(k) requirements. This decision aims at releaving manufacturers of those devices from some regulatory burden.
Meditrial has extensive experience on regulatory matters relating to medical device in the US and can help manufacturers to take the right actions and ensure compliance.
The order lists exempt and non-exempt product codes for five types of devices and details limitations to the exemptions for four of the device types. Details are shown in the table:
21 CFR Section |
Device type |
Exempt product code |
Non-exempt product code |
884.6120 |
Accessory, Assisted Reproduction |
QKH |
MQG |
884.6180 |
Media, Reproductive |
QKI |
MQL |
888.4505 |
Instruments Designed for Press-Fit Osteochondral implants |
Not applicable |
QBO |
890.5360 |
Interactive Rehabilitation Exercise Devices |
QKC |
LXJ |
890.5670 |
Massager, Therapeutic, to Internally Massage Trigger Points in the Pelvic Floor Musculature |
QKD |
OSD |
For more details, please see the order from the FDA.
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Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
