Additional Devices Exempted from 510(k) Submission

Additional Devices Exempted from 510(k) Submission

The US Food and Drug Administration released a final rule to exempt additional product codes from the requirements of 510(k) submission. FDA believes that this exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.1

The following product codes have been exempted under this new rule:2

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

FDA is also revising the name of the device type under product code LXJ from “System, Optical Position/Movement Recording” to “Interactive Rehabilitation Exercise Devices” and will update the codified language for the list of these devices to reflect this final determination.1

It should be noted that these exemptions have been granted with certain limitations and FDA has thus assigned new product codes for devices that are exempt subject to partial limitations to separate these devices from the ones that do not fall within the partial exemption limitation under the existing product code.2

Does your medical device fall within the product codes listed above? Give us a call today at 248-987-4497 or email us at info@emmainternational.com to learn how this rule impacts you.


1FDA (July 2020) Medical Devices; Exemptions From Premarket Notification: Class II Devices retrieved on 07/23/2020 from https://www.federalregister.gov/documents/2020/07/22/2020-15256/medical-devices-exemptions-from-premarket-notification-class-ii-devices

 

2RAPS (July 2020) FDA exempts additional Class II devices from 510(k) requirements retrieved on 07/23/2020 from https://www.raps.org/news-and-articles/news-articles/2020/7/fda-exempts-additional-class-ii-devices-from-510k

 

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