(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
and charge code language. Changes to the import alert are bracketed by asterisks (***).
The use of external penile rigidity devices may have harmful effects such as, aggravating existing medical conditions such as Peyronie's
disease, priapism, and urethral stricture. They may injure 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 ***discoloration of the
skin, typically caused by bruising*** 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.
These devices generally fall into the following categories and these products should follow the Class II Special Controls Guidance Document, External Penile Rigidity Device – Guidance for Industry and FDA Staff:
1. Vacuum pumps
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.
2. Constriction 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.
3. Penile splints
Those devices are flexible support structures intended to be attached to or placed along the penis to hold the penis erect during sexual intercourse. Penile splints include a quick release mechanism to
enable quick removal.
***The Red List of this Alert contains products where*** labeling falsely states or imply they will treat or improve the performance
of the following conditions or products:
• Mechanical penile extenders
• Foreskin remodeling or restoration
• Penile enhancement, such as penis enlargement
• Treatment of diseases or conditions of the penis with respect to
curvature and other penis deformities, e.g., Peyronie's Disease
• Prevention or reversal of erectile dysfunction/impotence
• Retaining a condom on the penis
A recommendation for addition to detention without physical examination should be forwarded to the Division of Import Operations (DIO). DIO will coordinate a review of all recommendations for addition to detention
without physical examination with CDRH, Imports and Registration and
Divisions may also be able to recommend a detention without physical examination of such devices under IA 89-08, "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices
Not Substantially Equivalent or Without a 510(k)."
Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:
***In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party of the affected goods should provide*** a written application (Form FDA 766) requesting authorization to bring a device that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning),
or by rendering it other than a device. ***All documentation should be submitted to the appropriate FDA Division compliance office for consideration per the "FDA Notice of Detention and Hearing." Divisions
will refer such applications related to this alert to CDRH, Imports and Registration and Listing Team for concurrence. For more information about reconditioning, refer to the FDA Regulatory Procedures Manual
(RPM), Chapter 9, "9-12 – Reconditioning," which is located on FDA's website. ***
Requests for removal from detention without physical examination (REMOVE FROM RED LIST):
In order to remove a firm's product from detention without physical examination, ***information should be provided to the Agency to adequately demonstrates that the firm has resolved the conditions that
gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). *** For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm ***and/or representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded*** to FDA at the following address:
Food and Drug Administration
Division of Import Operations (DIO)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
Questions or issues involving import operations, contact the Division of Import Operations at 301-796-0356 or email@example.com
Questions or issues on policy concerning these types of products or other compliance issues should be addressed to CDRH Imports and Registration
and Listing Team at firstname.lastname@example.org
whose label appears to not bear adequate directions for use."*** [Misbranding, Section 502(f)(1)]
OASIS CHARGE CODE: DIRECTIONS
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)