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FDA

510K Medical Device

In order for a personal lubricant to be sold and marketed in the United States, the FDA has started requiring all lubricants to have a Class II Medical Device 510(k) clearance. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalen, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to premarket approval. 510(k) clearance means that a company has done its due diligence with testing the product according to FDA guidelines and its been cleared for sale in the US. 

FDA Personal Lubricant Classification (FDA Link)

DeviceLubricant, Personal

Regulation DescriptionCondom.

DefinitionThis device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

Regulation Medical SpecialtyObstetrics/Gynecology

Review PanelObstetrics/Gynecology

Product CodeNUC

Premarket ReviewOffice of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)

Submission Type510(k)

Regulation Number884.5300

Device Class2

Total Product Life Cycle (TPLC)TPLC Product Code Report

GMP Exempt?No

Recognized Consensus Standard

Third Party ReviewNot Third Party Eligible



Here's a link to the FDA site and their declaration about reviewing all lubricants:  http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/ucm384132.htm

 "By December 31, 2015, review 100 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public."

World Health Organization Advisory Note: http://apps.who.int/iris/bitstream/10665/76580/1/WHO_RHR_12.33_eng.pdf
(
Page 3 lists Safety Issues regarding lubricants)



Helpful Links

FDA Premarket Notifications (510K) Information: (FDA Link)

FDA 510(k) Search Database (FDA Link)