IA #85-03, 9/12/94
SUBJECT : INTENSIFIED COVERAGE OF NOVELTY CONDOMS
TYPE OF ALERT: Intensified Coverage
PRODUCT : Novelty Products Which Appear to be Condoms (Condom-like
Products)
PRODUCT CODE : 85HIS
HARMONIZED
CODE : 4014.10.00-00-4
PROBLEM : Novelty products which appear to be condoms are being
confused with medical device condoms. In order to be
considered as an unregulated novelty product, a condom-like
product must have been rendered incapable of functioning as
a condom, and must not have any medical claims in its
labeling or promotional materials. A product which is
usable as a condom is a medical device and must comply with
all applicable requirements (see the February 23, 1994,
letter from the Director, Office of Compliance, CDRH).
PAC FOR
COLLECTION : 82008
COUNTRY : All
MANUFACTURER/
SHIPPER : All
CHARGE : NOTE: A product which appears to be intended for use as a
condom, see 21 CFR 884.5300 (or 5310) a "closely fitting
membrane" which "completely covers the penis", and which
has
not been rendered unusable is a medical device regardless
of
humorous packaging, labeling, and/or disclaimers. For such
a device which is not listed, and/or which does not have an
approved premarket approval application (PMA) or
substantial
equivalency order, (510(k)), charge:
1. Failure to list:
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears that
the article was not included in a list required by
Sections 510(i)(j) and 502(o) and 21 CFR 807.40 of
the Food, Drug, & Cosmetic Act [Misbranding,
502(o)]."
2. Failure to obtain approval of a premarket approval
application or a substantial equivalency order:
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to
be a post amendments device for which it appears
that a premarket application has not been approved
and a substantial equivalency order (510(k)) has
not been granted. [Adulteration, 501(f)(1) and
Misbranding, 502(o)]."
3. Some condoms may be considered as "novelties" because
of humorous or novel packaging, but actually are in
compliance with the applicable listing and premarket
notification requirements. If the novelty
manufacturer has not altered the condom or its
primary package labeling, these devices may be
acceptable
provided that they are distributed with the same, or
substantially similar, instructions for use that were
submitted in the 510(k) for the device.
If the devices lack instructions for use, charge:
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that its labeling
appears to fail to bear adequate directions for its
intended use [Misbranding, 502(f)(1)]."
RECOMMENDING
OFFICE : CDRH, Office of Compliance,
Division of Enforcement II, HFZ-300
REASON FOR
ALERT : In recent years, there has been an increase in the
popularity of novelty products which appear to be intended
for use as condoms. Increased emphasis has been placed
upon the importance of using condoms to serve as a barrier
to sexually transmitted diseases, (STD) including AIDS.
Consumers may assume that these novelty products will
provide the degree of protection expected of a condom, even
though the products have not met the testing requirements
for legitimate condoms. The use of such products, with no
assurance as to their safety and quality, can pose a danger
to health. Based on these concerns, a decision was made to
clarify the FDA's policy regarding "novelty condoms" which
can function similarly to condoms.
In a letter dated February 23, 1994, CDRH informed
manufacturers, distributors, and importers of functional
novelty condom-like products that, "These products by form
and function meet the definition of a condom as defined in
21 CFR 884.5300 and must, therefore, comply with all
requirements for condoms including leak testing, compliance
with Good Manufacturing Practices regulations, manufacturer
registration, product listing, and pre-market notification
and clearance." Because individuals and firms distributing
these products may not be registered, they may not have
received the February 23 letter. We believe that many
foreign manufacturers are also unaware of the modified
policy and continue to ship misbranded and adulterated
"novelty condoms" to the U.S.
INSTRUCTIONS : Inspect shipments of novelty products which appear to be
condoms to determine whether the products can function as
a
condom.
1. If the product has been rendered unusable, e.g. by
removing the closed end, by sealing the rolled condom
so that it cannot be unrolled, by embedding the
condom
in plastic etc., then the product is truly an
unregulated novelty product. If no medical claims
are
present in the labeling, the shipment may be released
without further investigation.
2. If the product can function as a condom, then use
standard procedures to check CDRH's databases for
product listings and 510(k)'s. Also, check to
confirm
that the importer has registered and listed.
a. If the products do not have the required
listings and premarket notifications, detain
the
shipment.
b. Some importers may not be aware of the
registration requirements. If the importer has
not registered, the shipment should not be
released to that importer until the required
forms have been filed.
c. If products are listed and have 510(k)'s, and
the importer is registered, then examine the
labeling. Products with inadequate labeling
(such as lack of adequate directions for use)
should be detained.
d. If the products have the required listings and
premarket notifications, and if the importer
has
registered, and a review of the labeling finds
it to be adequate, then such products should be
treated as normal imported condoms, (i.e. the
shipment should be subjected to the routine FDA
water leak test applied to imported condoms
under IA 85-02). Subsequent to passing this
test, the shipment may be released.
CONTACTS: Questions regarding whether a specific product meets the
functional definition of a condom should be directed to
Byron Tart, PAPS, OC, CDRH, (301) 594-4639.
Questions regarding whether a listing or a 510(k) exists
for
a specific product, regarding medical claims, or regarding
required labeling can be directed to John Farnham, DOEII,
OC, CDRH, (301) 594-4616.
FOI : No purging is required.
KEYWORDS : Condoms, Novelty Condoms
PREPARED BY : Rosa K. Forehand, DIOP (301)443-6553
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