Import Alert 85-01
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 85-01
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Sponges for Menstrual Care"
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.
Guidance:
Districts may detain, without physicla examination, 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.
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.
Product Description:
Menstrual Sponges
Charge:
"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)]."
OASIS charge code - NO PMA
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)]."
OASIS charge code - DIRECTIONS
OASIS charge code - NO PMA
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)]."
OASIS charge code - DIRECTIONS
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(79 G - - ER) Sponge, External
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