The agency plans to finalize a ban in December that would apply to electrical stimulation devices used to treat self-injurious or aggressive behavior. According to the proposed rule, the “FDA has determined that these devices present substantial and unreasonable risks of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling.”
To date, the FDA has only banned two types of medical devices: powdered medical gloves in 2017 and prosthetic hair fibers in 1983.
The rule to establish an over-the-counter category of hearing aids is intended to promote the availability of products to treat age-related hearing loss and will be voted on in November. The move has been met with lobbying from the hearing aid industry, according to MedTech Dive.
The rule to streamline Medicare coverage of breakthrough devices will be voted on in December and is intended to increase patients’ access to devices that use new forms of technology.
The FDA plans to vote in November on a proposed rule to change the way humanitarian device exemption approvals and denials are announced.
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