Based on the US policy, any medical device in introduction or delivery for commercial distribution is required to submit a 510k to FDA to provide the safety and effectiveness assurance for the device. According to Act amended section 510(m) of the FD&C Act, FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of some medical devices. Therefore, FDA has published the order on "Federal Register" for the following devices that don't need to submit the 510k.

Table 1: The list of class II device that no longer requires 510k, but if the product meets any conditions in 21 CFR 884.9, 888.9, and 890.9, it would be required to submit 510k.

21 CFR section 

Device type

Exempt product code

Non-exempt product code (non-exempt)

Partial exemption limitation (if applicable)


Accessory, Assisted Reproduction 



Exemption is limited to assisted reproduction laminar flow workstations. 


Media, Reproductive 



Exemption is 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.


Instruments Designed for Press-Fit Osteochondral implants 

Not Applicable 


Not Applicable. 


Interactive Rehabilitation Exercise Devices 



Exemption is limited to prescription (Rx) use only. 


Massager, Therapeutic, to Internally Massage Trigger Points in the Pelvic Floor Musculature 



Exemption is limited to prescription (Rx) use only devices which incorporate a quantitative feedback mechanism and a disposable covering. 

Depending on FDA's criteria for exemption, limitations on exemptions, and experience, the Class II products in Table 1 above are not required to provide a reasonable assurance of safety and effectiveness. However, if the product does not match the characteristics with predicate devices, a 510k would still be required to submit. In addition to that, products which meet the description in 21 CFR 884.9, 888.9, and 890.9. FDA will require the product to submit 510k. 

Moreover, FDA may also partially limit an exemption from 510k requirements to specific devices on the listed device. For example, the optical position/movement recording system is on the list of exemption, but if the product's indicated use is for over the counter (OTC), it would exceed the exemption limitation and would require 510(k) review. So, it is always a better idea to consult with FDA prior to deciding to exempt it from the 510(k) review and placing in the market.


Medical Devices; Exemptions From Premarket Notification: Class II Devices