IA #78-01 - 8/20/08, REVISION TO IMPORT ALERT #78-01, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF PENIS ENLARGERS AND ERECTION MAINTAINING RINGS"
*** The revision of this Alert dated 8/20/08 is to revise the Guidance. Also,
the attachment list of specific firms was removed from this alert since
the alert applies to all manufacturers of all such devices. ***
TYPE OF ALERT: *** Detention Without Physical Examination, (DWPE) ***
NOTE: This import alert contains guidance to FDA field personnel only. It does
not establish any requirements, or create any rights or obligations on FDA
or on regulated entities.
PRODUCT: Penis Enlargers
Erection Maintaining Devices
PRODUCT CODE: 78-----
PROBLEM: Inadequate directions for use
PAC FOR
COLLECTION: 82008
COUNTRY: All
MANUFACTURER
OR SHIPPER: All
MANUFACTURER
OR
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. #: N/A
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a device, the label
of which fails to bear adequate directions for use
[Misbranding, Section 502(f)(1)]."
*** OASIS
Charge Code: DIRECTIONS ***
RECOMMENDING
OFFICE: Division of Import Operations & Policy, HFC-170 and CDRH, HFZ-
323
REASON FOR
ALERT: The use of penis enlargers and erection maintaining rings may
have harmful effects. They may aggravate existing medical
conditions such a Pegronies disease, priapism, and urethral
stricture. They may contuse or cause rupture of the
subcutaneous blood vessels, which may produce hemorrhage and
hematoma formation. Additionally, frequent use of erection
maintaining rings may result in ecchymosis of the proximal
portion of the penis and scrotum, and the lymphatic stasis of
the penis. Prolonged use of the rings may cause gangrene of
the penis.
Basically, the labeling of these devices falsely states or
implies they will treat impotence, prolong erection, and
increase the dimensions of the penis.
These devices generally fall into the following categories:
1. Mechanical stretching devices.
Those employing weights, or lines tied to other parts of
the body (such as the knee), to affect tension on the
penis.
2. Vacuum operated devices.
Those employing a sealing principle in the area of the
base of the penis and an evacuation mechanism to drop
the atmospheric pressure around the penis thereby
effecting increased blood flow.
3. Constrictive Rings.
Those devices which constrict the base of the penis
after erection has been achieved and cause the erection
to be maintained by blocking the normal circulation of
blood from the penis.
4. Supportive devices.
Those devices which function as a splint or cradle in
order to maintain a resemblance of turgidity
*** GUIDANCE: Districts may detain without physical examination, unless
exempted by 21 CFR, Section 801.109, all devices in the above
described categories. Districts may also be able to detain
such devices under IA 89-08, "DWPE of devices w/o approved
PMA's or IDE's and other devices not equivalent or no 510K."
If there is any question whether or not any device encountered
falls into the above described categories, contact CDRH,
Division of Compliance Operations, HFZ-332, at 240-276-0339.
***
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging is required
KEYWORDS: Erection Maintaining Devices, Penis Enlargers, Constrictive
Rings, Supportive Devices
PREPARED BY: Emilio Escobar, DIOP, 301-443-6553
DATE LOADED
INTO FIARS: August 20, 2008
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