C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES › Subpart F—Obstetrical and Gynecological Therapeutic Devices

21 C.F.R. § 884.5460

Scented or scented deodorized menstrual tampon

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) Identification. A scented or scented deodorized menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.

(b) Classification. Class II (performance standards).

[45 FR 12684, Feb. 26, 1980, as amended at 45 FR 51186, Aug. 1, 1980]
Notes of Decisions
Cited in 16 cases, 1987–2001 · leading case: Kandis L. Papike v. Tambrands Inc., 107 F.3d 737 (9th Cir. 1997).
Sort: Relevance Newest Treatment
Kandis L. Papike v. Tambrands Inc., 107 F.3d 737 (9th Cir. 1997). “21 C.F.R. §§ 884.5460 , 884.5470 (1996). Use of Class II devices involves some risk of injury, so manufacturers of these devices must comply with federal regulations known as “special controls.”
Bravman v. Baxter Healthcare Corp., 842 F. Supp. 747 (S.D.N.Y. 1994). “See 21 C.F.R. § 884.5460 (scented) and § 884.”
Stewart v. Int'l Playtex, Inc., 672 F. Supp. 907 (D.S.C. 1987). “21 C.F.R., Section 884.5460 and 21 C.F.R.”
prod.liab.rep. (Cch) P 15,173 Martha Haddix v. Playtex Fam. Prods. Corp., 138 F.3d 681 (7th Cir. 1998). “” 21 C.F.R. §§ 884.5460 and 884.5470 (1997).”
Berger v. Pers. Prods., Inc., 797 P.2d 1148 (Wash. 1990). “12 , 715-18 (1980); see also 21 C.F.R. § 884.5460 ; 21 C.F.R § 884.5470 (1988).”
Reece v. Good Samaritan Hosp., 953 P.2d 117 (Wash. Ct. App. 1998). “A Class II medical device is one that poses some risk of injury to the user, so the manufacturers of these devices must comply with federal performance regulations known as “special controls.” 21 U.S.C. § 360c(a)(l)(B) (1994) (as amended in 1990).”
Meyer v. Int'l Playtex, Inc., 724 F. Supp. 288 (D.N.J. 1988). “21 C.F.R. §§ 884.5460 and 884.5470. The Amendments further provide that "The Secretary may by regulation, promulgated in accordance with this section, establish a performance standard for a Class II device.”
Lindquist v. Tambrands, Inc., 721 F. Supp. 1058 (D. Minn. 1989). “§§ 360c; 21 C.F.R. §§ 884.5460 , 884.5470. In enacting the MDA in 1976, Congress intended to assure “that Americans are not put at risk from the use of unsafe and ineffective medical devices.”
Ginochio v. Surgikos, Inc., 864 F. Supp. 948 (N.D. Cal. 1994). “See 21 C.F.R. §§ 884.5460 and 884.5470. And the FDA has promulgated a regulation specifying the toxic shock warning that all tampons must include.”
Murphy Ex Rel. Murphy v. Playtex Fam. Prods. Corp., 176 F. Supp. 2d 473 (D. Md. 2001). “21 C.F.R. §§ 884.5460 , 884.5470 (2000) (Def.”
Moore v. Kimberly-Clark Corp., 676 F. Supp. 731 (W.D. La. 1987). “See 21 C.F.R. §§ 884.5460 and 884.5470. The Amendments provide that the Secretary may by regulation establish a performance standard for a Class II device.”
Bejarano Ex Rel. Bejarano v. Int'l Playtex, Inc., 750 F. Supp. 443 (D. Idaho 1990). “” 21 C.F.R. §§ 884.5460 , 884.8570. The FDA concluded that TSS is a rare but serious and sometime fatal disease .”
Show all 16 citing cases →
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.