News & Analysis as of

Food and Drug Administration (FDA) Retailers Medical Devices

Morgan Lewis - As Prescribed

Distribution Chain Compliance for Medical Devices

Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding requirements for device...more

Clark Hill PLC

Retailers Looking To Sell Hearing Aids Over the Counter Must Meet the Applicable FDA Medical Device Rules

Clark Hill PLC on

On Oct. 17, the U.S. Food and Drug Administration’s (FDA) final rule on over-the-counter (OTC) hearing aids took effect which now allows any person, 18 years of age or older, to buy or lease a hearing aid for mild to moderate...more

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