FDA Policy/General

Five Class 2 Devices Exempt from 510(k)

Federal Register notice: FDA has announced its decision to exempt a list of Class 2 devices from premarket notification requirements. Comments are being accepted until 12/24 on the exempt devices. They are:

Accessory, Assisted Reproduction (product code MQG): Exemption is limited to assisted reproduction laminar flow workstations
Media, Reproductive (product code 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.
Instruments Designed for Press-Fit Osteochondral implants (product code QBO)
System, Optical Position/Movement Recording — Interactive Rehabilitation Exercise Devices (product code LXJ): Exemption is limited to prescription-use only
Massager, Therapeutic, to Internally Massage Trigger Points in the Pelvic Floor Musculature (product code OSD)

To view the notice, click here.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome