FDA New Update: Class II Devices and 510(K) Exemptions

Two years ago, in 2017, the Food and Drug Administration (FDA) identified a tentative list of Class II medical devices to be exempted from premarket notification requirements. The list came with limitations for certain type of devices then. Referring to the same, the FDA on Oct 24, 2019, announced the proposed final list of Class II devices to be exempted from 510(k) requirements. The latest proposed exemptions follow the finalization of a list published in July 2017 that comprises of 1,003 types of Class II devices. The Agency also reported, the devices mentioned in the list no longer require premarket notification to provide reasonable assurance of safety and effectiveness.

Below is the list of class II devices FDA has identified that would no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions:

21 CFR Section

Device Type

Product Code

Partial Exemption Limitation
(if applicable)

884.6120

Accessory, Assisted Reproduction

MQG

Exemption is limited to assisted reproduction laminar flow workstations.

884.6180

Media, Reproductive

MQL

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.

888.4505

Instruments Designed for Press-Fit Osteochondral implants

QBO

 

890.5360

System, Optical Position/Movement Recording (Interactive Rehabilitation Exercise Devices)

LXJ

Exemption is limited to prescription (Rx) use only

890.5670

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

OSD

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

Source: https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-23308.pdf

In the most recent notice, the Agency stated that the exemptions have been categorized under five different product codes such as:

  • optical position/movement recording system
  • internal therapeutic massager
  • accessory used in assisted reproduction
  • instrument for press-fit osteochondral implants, and
  • a phosphate-buffered saline solution

Although there are some exemptions involved, four out of five of recent product codes proposed have certain limitations. For Example, FDA is limiting the proposed exclusion of optical position/movement recording systems to such devices that are for prescription use only. Another exemption is proposed for assisted reproduction accessories, which are also limited to assisted reproduction laminar flow workstations.

Are you a device manufacturer of any of the mentioned 5 different product codes? Then you must classify device according to the new list. For any assistance on device classification and compliant market entry, consult a Regulatory expert now.