(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:
The use of ***external penile rigidity devices*** may have harmful effects. They may aggravate existing medical conditions such as Peyronie's 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.
These devices generally fall into the following categories:
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 labeling of these products should follow the Class II Special Controls Guidance Document, External Penile Rigidity Device – Guidance for Industry and FDA Staff.
The labeling of these devices 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 and background information, including labeling, package inserts, website information, etc., should be forwarded to DIO, if labeling claims are found. DIO will coordinate a review of all recommendations for addition to detention without physical examination with CDRH, Imports and Registration and Listing Team.
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:
The importer of record may submit to the FDA 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. Divisions will refer such applications related to this alert to CDRH, Imports and Registration and Listing Team for concurrence.***
***Additional Reference- Class II Special Controls Guidance Document: External Penile Rigidity Devices - Guidance for Industry and FDA Staff: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/class-ii-special-controls-guidance-document-external-penile-rigidity-devices-guidance-industry-and
For more information about reconditioning, refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9, "9-12 - Reconditioning." The RPM is located at FDA's website: https://www.fda.gov/media/71776/download***
***Requests for removal from detention without physical examination under this import alert:
In order for FDA to consider removing a firm and/or product from detention without physical examination, FDA must have evidence which establishes the conditions that gave rise to the apparent violation have been resolved and which gives FDA confidence that future entries will be in compliance with the Act. Therefore, it is expected the firm, and/or an agent thereof will submit information outlining the firm's investigation into the root cause of the violation as well as any follow-up steps taken to prevent violations in future shipments.
For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)." https://www.fda.gov/media/71776/download
If a firm, shipper or importer would like to request removal from detention without physical examination, they should forward information supporting their request 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
DIO will coordinate the evaluation of a request for removal from detention without physical examination with CDRH, Imports and Registration and Listing Team.
For questions involving import operations, contact the Division of Import Operations at 301-796-0356, or email firstname.lastname@example.org
For questions concerning these types of products or other compliance issues, contact CDRH Imports and Registration and Listing Team, 240-402-4020, or email: email@example.com
Questions or issues involving Operational and Administrative System for Import Support (OASIS) or Predictive Risk Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) screening contact ORA/DSS/Import Systems Branch firstname.lastname@example.org ***
***Product Code: 78LKY***
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)