21 C.F.R. § 884.5980

Surgical mesh for transvaginal pelvic organ prolapse repair

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(a) Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).

(b) Classification. Class III (premarket approval).

(c) Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.

[81 FR 361, Jan. 5, 2016, as amended at 81 FR 369, Jan. 5, 2016]

Notes of Decisions

Cited in 7 cases (5 in the last 5 years), 2020–2023 · leading case: Barbara Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020).

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Barbara Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020). “See 21 C.F.R. § 884.5980 . D. Kaiser’s Surgery and Lawsuit Kaiser suffered from a severe anterior pelvic-organ pro- lapse.”

Elizabeth Hrymoc Vs. Ethicon, Inc. Mary Mcginnis Vs. C.R. Bard, Inc. (l-13696-14 & L-17543-14, Bergen Cnty. & Statewide) (Consol.) (N.J. Super. Ct. App. Div. 2021). · cites it 2× “5, 2016) (the "Reclassification Action Summary") (summarizing the history of surgical mesh and transvaginal mesh classifications) (codified at 21 C.F.R. § 884.5980 (2016)). A-5151-17 23 manufacturers to identify and describe the device, state its intended use, specify all…”

Elizabeth Hrymoc Vs. Ethicon, Inc. Mary Mcginnis Vs. C.R. Bard, Inc. (l-13696-14 & L-17543-14, Bergen Cnty. & Statewide) (Consol.) (N.J. Super. Ct. App. Div. 2021). · cites it 2× “5, 2016) (the "Reclassification Action Summary") (summarizing the history of surgical mesh and transvaginal mesh classifications) (codified at 21 C.F.R. § 884.5980 (2016)). A-5151-17 64 manufacturers to identify and describe the device, state its intended use, specify all…”

Barbara Kaiser v. Johnson & Johnson (7th Cir. 2020). “See 21 C.F.R. § 884.5980 . D. Kaiser’s Surgery and Lawsuit Kaiser suffered from a severe anterior pelvic-organ pro- lapse.”

Elizabeth Hrymoc v. Ethicon, Inc. (N.J. 2023). “21 C.F.R. § 884.5980 . 7 The predicate device for the Avaulta Solo was the “Avaulta Support System,” which was cleared in 2007.”

Bergman v. Johnson & Johnson (D. Minnesota 2021). “Budnik has been discontinued and was categorized by the Food and Drug Administration as a Class III medical device, regulated under 21 C.F.R. § 884.5980 , while the two products used on Ms.”

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