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We've imported "pleasure" toys into the US for more than a year now, but our latest shipment is in detention, with the following problem/problems:
502(o), 801 (a)(3) misbranding
that the device or devices are subject to listing under 510(j) or (k) and that we have not pre-registered the devices, or ourselves as the initial importers.
The devices are dildos, vibrating dildos, male masturbation cups, etc. Not what we thought was subject to FDA regulation as "medical devices".
Anyone have any experience in this area or know someone who does?
NOTE: Although this discussion is over 6 years old, Google is now making more changes to it's "review" algorithm and has "flagged" this discussion. They are not human reviews. If they were, it would be obvious to them that simply having the words "sex toys" in a discussion does not, or should not, classify this discussion as "Adult: REDACTED Content" yet Google has sent an "Your AdSense Publisher Policy Violation Report" to us despite the fact that it is solely related to medical device classifications. Because this discussion contains information solely related to Medical Device classifications we have decided not to remove the thread.
502(o), 801 (a)(3) misbranding
that the device or devices are subject to listing under 510(j) or (k) and that we have not pre-registered the devices, or ourselves as the initial importers.
The devices are dildos, vibrating dildos, male masturbation cups, etc. Not what we thought was subject to FDA regulation as "medical devices".
Anyone have any experience in this area or know someone who does?
NOTE: Although this discussion is over 6 years old, Google is now making more changes to it's "review" algorithm and has "flagged" this discussion. They are not human reviews. If they were, it would be obvious to them that simply having the words "sex toys" in a discussion does not, or should not, classify this discussion as "Adult: REDACTED Content" yet Google has sent an "Your AdSense Publisher Policy Violation Report" to us despite the fact that it is solely related to medical device classifications. Because this discussion contains information solely related to Medical Device classifications we have decided not to remove the thread.
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