Treatment of erectile dysfunction in adult males aged 22 years and over.

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.06 . 0 2

Silver Spring, MD 20993

www.fda.gov

June 9, 2023

Re: DEN220078

Trade/Device Name: Eroxon

Regulation Number: 21 CFR 876.5021

Regulation Name: Non-medicated topical formulation for treatment of erectile dysfunction

Regulatory Class: II

Product Code: QWW

Dated: January 4, 2023

Received: March 28, 2023

Dear Ken James:

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has

completed its review of your De Novo request for classification of the Eroxon, an over-the-counter device

under 21 CFR Part 801 Subpart C with the following indications for use:

Treatment of erectile dysfunction in adult males aged 22 years and over.

FDA concludes that this device should be classified into Class II. This order, therefore, classifies the

Eroxon, and substantially equivalent devices of this generic type, into Class II under the generic name non-

medicated topical formulation for treatment of erectile dysfunction.

FDA identifies this generic type of device as:

Non-medicated topical formulation for treatment of erectile dysfunction. A non-medicated

topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and

stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.

Section 513(f)(2) of the Food, Drug and Cosmetic Act (the FD&C Act) was amended by section 607 of the

Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This law provides two

options for De Novo classification. First, any person who receives a "not substantially equivalent" (NSE)

determination in response to a 510(k) for a device that has not been previously classified under the Act may

request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act. On

December 13, 2016, the 21st Century Cures Act removed a requirement that a De Novo request be submitted

within 30 days of receiving an NSE determination. Alternatively, any person who determines that there is no

DEN220078 - Ken James Page

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legally marketed device upon which to base a determination of substantial equivalence may request FDA to

make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a

510(k). FDA shall, within 120 days of receiving such a request, classify the device. This classification shall

be the initial classification of the device. Within 30 days after the issuance of an order classifying the device,

FDA must publish a notice in the Federal Register announcing the classification.

On October 21, 2022, FDA received your De Novo requesting classification of the Eroxon. The request was

submitted under section 513(f)(2) of the FD&C Act. In order to classify the Eroxon into class I or II, it is

necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance of the

safety and effectiveness of the device for its intended use. After review of the information submitted in the

De Novo request FDA has determined that, for the previously stated indications for use, the Eroxon can be

classified in class II with the establishment of special controls for class II. FDA believes that class II

(special) controls provide reasonable assurance of the safety and effectiveness of the device type. The

identified risks and mitigation measures associated with the device type are summarized in the following

table:

Risks to Health

Mitigation Measures

Failure to identify correct population and

condition, leading to ineffective use

Labeling

Deleterious effect on condoms leading to

pregnancy or transmission of sexually

transmitted infections

Non-clinical performance testing

Labeling

Shelf-life testing

Adverse tissue reaction

Biocompatibility testing

Labeling

Non-clinical performance testing

Pain or discomfort

Non-clinical performance testing

Labeling

Shelf-life testing

In combination with the general controls of the FD&C Act, the non-medicated topical formulation for

treatment of erectile dysfunction. is subject to the following special controls:

(1) The device must be demonstrated to be biocompatible.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under

anticipated conditions of use. The following performance characteristics must be tested:

(i) Condom compatibility;

(ii) Temperature profile evaluation; and

(iii) Verification of device specifications.

(3) Performance data must support the shelf life of the device by demonstrating the device meets its

specifications over the identified shelf life.