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News We’re Watching – 13 January

 
• By Elizabeth Orr and Hannah Daniel

This new Medtech Insight feature compiles news briefs on a range of regulatory and legal happenings. This week: Guidance documents on photobiomodulation devices and COVID-19 submissions; legal settlements for Abbott and Jet Medical; and a new partnership for Pear Therapeutics.

"News We're Watching" Feature Image
• Source: Medtech Insight

The US Food and Drug Administration published a draft guidance for 510(k) submissions of photobiomodulation (PBM) devices, also known as low level light therapy devices, on 12 January. The guidance applies to class II PBM devices and provides information for their labeling and testing requirements. The guidance also applies to PBM devices that are components of other devices, such as ultrasounds, massagers, or electrostimulation devices.

Comments are open until 13 March and can be submitted through this docket.

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