RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
Regulatory Focus™ > News Articles > 2019 > 10 > FDA Proposes Additional Class II Devices to be Exempt From 510(k) Requirements

FDA Proposes Additional Class II Devices to be Exempt From 510(k) Requirements

Posted 24 October 2019 | By Zachary Brennan 

FDA Proposes Additional Class II Devices to be Exempt From 510(k) Requirements

Thanks to the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Thursday proposed to exempt additional class II medical devices under five different product codes from 510(k) requirements.

The proposed exemptions follow the finalization of a list in July 2017 of 1,003 types of class II devices that the agency also said do not present risks that require premarket notification.

But for four of the five product codes proposed on Thursday, FDA has limited the exemptions to certain devices within that product code. For example, FDA is limiting the proposed exemption of optical position/movement recording systems to such devices that are for prescription use only.

“FDA believes that FDA review (e.g., premarket notification) of an optical position/movement recording system for over-the-counter (OTC) use is necessary to ensure that the exercises and activities led by the system are appropriate for a user’s rehabilitation and to assess the measurement accuracy of the system,” the agency said.
“Additionally, a therapeutic massager to internally massage trigger points in the pelvic floor musculature would exceed the exemption limitation and would require 510(k) review if it is indicated for OTC use, lacks a quantitative feedback mechanism, or lacks a disposable covering.”

The exemption proposed for assisted reproduction accessories is also limited to assisted reproduction laminar flow workstations.

And the exemption for reproductive media and supplements 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 would also be exempt if the proposal is finalized.

The agency further said that it will ensure exempt and nonexempt devices within a device type will have distinct product codes.

“FDA is also revising the name of product code LXJ to further clarify the device type that this product code is intended to represent. The device type was previously ‘System, Optical Position/Movement Recording.’ This product code also includes types of rehabilitation devices other than optical position/movement recording systems; therefore, to more accurately reflect the devices which fall within this device type (product code LXJ), the device type has been renamed ‘Interactive Rehabilitation Exercise Devices,’” FDA said.

Device Classifications

Also on Thursday, FDA announced it is classifying the internal therapeutic massager into class II (special controls) because it believes this move will enhance patients’ access to "beneficial innovation."

The agency also said it is classifying the orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls).

Federal Register

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe