Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD Protection | Guideline Explorer

Description

DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health ServiceFood and Drug Administration9200 Corporate BoulevardRockville MD 20850

Scope & Applicability

Product Classes

4

Barrier Devices

intended for protection from sexually transmitted diseases (STDs) during oral sex

Class III Device

Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.

Latex condoms

barrier product to protect users from the transmission of STD microorganisms; used as off-the-shelf comparative samples

Class III

Class III subject to the 510(k) or PMA requirements

Stakeholders

3

Prospective Manufacturers

entities intended to produce barrier devices for oral sex

Manufacturer

Entity responsible for submitting NDINs

official correspondent

Person in the firm responsible for the 510(k) statement

Regulatory Context

Attributes

3

Expiration date

should be based on appropriate supportive stability data

Transmembrane condom pressure

Physical parameter to be reported in test results

Sterility assurance level

support the use of the proposed cycle and the desired sterility assurance level

Identified Hazards

Hazards

1

Virus transmission

The risk the barrier device is intended to prevent

Related CFR Sections (6)

21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
21CFR884.5300§ 884.5300 Condom.
(a) Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagRead full regulation →
21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
21CFR807.93§ 807.93 Content and format of a 510(k) statement.
(a)Read full regulation →
21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →

Related Warning Letters (2)

Medical Devices/Adulterated/Quality System Regulation (QSR)
iRhythm Technologies, Inc.
2023-06-06
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Tenderneeds Fertility LLC
2020-04-21