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While the FDA focuses most of its energies on the pre-market review process for approving devices, it should not neglect the post-market surveillance system.
Policymakers should ensure that the FDA’s process for approval and oversight of medical devices to protect public health and safety is thorough, efficient, and not unduly burdensome.
Device companies should be prohibited from promoting a device for uses not approved by the FDA.
Congress should enact legislation that would provide patients with legal recourse if they are injured by a defective or malfunctioning implanted medical device.
Policymakers should increase transparency and competition in the market for medical devices.
Policymakers and regulators should make necessary changes to help lower the cost and promote greater adoption of hearing aids.
The Federal Communications Commission should ensure full and prompt implementation of its hearing-aid compatibility rules to increase the number of wireless phones that can be used effectively with