Devices

FDA Warns Companies on Unapproved CPAP Cleaners

FDA has sent Warning Letters to three companies marketing CPAP cleaning/sanitizing products without agency clearance or approval. The letters were sent on 8/7 or 8/8 to Shenzhen Moyeah Intelligent Life Technology Co. in Guangdong Sheng, China; Leel Tech in Guandong Sheng, China; and Adventure Innovations in South Jordan, UT.

The Shenzhen Moyeah letter lists the devices the firm is illegally marketing and the Web site claims being made for them. It says the firm did not respond to a 5/26/2021 letter from the agency or FDA’s 3/3/2023 and 4/21/2023 email follow-ups. Shenzhen Moyeah was told to cease any activities that result in its devices being misbranded or adulterated, including distributing them for the identified uses. The firm was told to respond with a list of specific steps it has taken to address violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

The Leel letter identifies three CPAP cleaning/sanitizing devices the firm is marketing in the U.S. without clearance or approval and the claims made for them. FDA says that in response to a 5/10/2023 letter from the agency, Leel indicated that it is an agent for the cleaning devices and does not directly produce or manufacture them and thus intended to continue selling its remaining inventory. FDA says the response did not address the lack of clearance or approval for the devices and reminded Leel that importing unapproved devices into the U.S. and distributing them to customers is illegal. The firm was told to respond with a list of specific steps it is taking to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

In the letter to Adventure Innovations, FDA identified one CPAP cleaning device it is illegally marketing and the claims being made for it. The firm was told to respond with a list of specific steps it is taking 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

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome