Devices

RoyalVibe Health Refused Inspection: FDA

A 6/17/22-7/5/22 attempted FDA inspection at RoyalVibe Health, The Woodlands, TX, determined that the firm manufactures, markets, and distributes several medical devices and associated software and apps. A just-released 11/18/22 Warning Letter says the company does not have an approved PMA or IDE for its products.

The products are considered misbranded, the letter says, because the firm did not notify FDA of its intent to introduce the devices into interstate commerce.

The letter lists claims made for the company’s devices that establish they are legally considered to be medical devices.

FDA says RoyalVibe did not meet its 2022 registration requirement with the agency and also says the firm refused to permit an agency inspection at its address in The Woodlands.

FDA acknowledges the firm’s commitment to stop offering its products for sale in the U.S. until it achieved compliance with the regulations. But the agency says the response did not address previously marketed and distributed adulterated devices. It also noted that a review of the firm’s Web sites determined that customers continue to have an opportunity to purchase the devices in the U.S.

The firm was told to take prompt action to correct any violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

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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