The revision updates and reformats the information in this
alert.
TYPE OF ALERT: Automatic Detention
PRODUCT : Menstrual Sponges
PRODUCT CODE : 80----
HARMONIZED
CODE : N/A
PROBLEM : Inadequate directions for use (DRDW)
Lack of premarket approval (PMA)(DVUU)
PAC FOR
COLLECTION : 82002
COUNTRY : All
MANUFACTURER/
SHIPPER : All
MANUFACTURER/
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. # : N/A
CHARGES :
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that the device
appears to be a Class III device and does not
appear to have in effect an approved application
for premarket approval pursuant to Section 515 of
the Act, or an exemption pursuant Section 520 (g)
[Adulteration, Section 501(f)(1)]."
and/or
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears
to be a device, the label of which fails to
bear adequate directions for use [Misbranding,
Section 502(f)(1)]."
RECOMMENDING
OFFICE : CDRH/Office of Compliance, HFZ-323
REASON FOR
ALERT : In 1980 an apparent link between Toxic Shock
Syndrome, and the use of tampons prompted interest
in alternative methods of menstrual care. One of
these is the use of sponges which are cut into
appropriate shapes and sizes then used as a tampon.
Some labeling advocates the reuse of the sponges
simply by removing the device and washing it out.
INSTRUCTIONS : Automatically detain shipments of sponges labeled
for use as tampons, or suspect for use in menstrual
care, but lack premarket approval and/or fail to
bear adequate directions for use. Shipments of
sponges found in compliance should be released.
Intended uses of unlabeled sponges should be
determined by contacting the consignee.
Shipments of sponges for cosmetic or other non-
medical use should not be detained.
PRIORITIZATION
GUIDANCE : N/A
FOI : No purging is required
KEYWORDS : Menstruation, Sponges, PMA, Menstrual Care,
Menstrual
Sponges, Tampons
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.
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