C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 876—GASTROENTEROLOGY-UROLOGY DEVICES › Subpart D—Prosthetic Devices

21 C.F.R. § 876.3750

Testicular prosthesis

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(a) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.

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

(c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before July 5, 1995, for any testicular prosthesis that was in commercial distribution before May 28, 1976, or that has on or before July 5, 1995, been found to be substantially equivalent to a testicular prosthesis that was in commercial distribution before May 28, 1976. Any other testicular prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 60 FR 17216, Apr. 5, 1995]
Notes of Decisions
Cited in 4 cases, 1995–2008 · leading case: Jessen v. Mentor Corp., 71 Cal. Rptr. 3d 714 (Cal. Ct. App. 2008).
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Jessen v. Mentor Corp., 71 Cal. Rptr. 3d 714 (Cal. Ct. App. 2008). “56, 59 [no triable issue of fact whether Mentor large testicular prosthesis, which contained reinforced, molded silicone elastomer, was Class III medical device] ).”
Goldsmith v. Mentor Corp., 913 F. Supp. 56 (D.N.H. 1995). · cites it 2× “The FDA lists “testicular prosthesis” as a “Class III” medical device, 21 C.F.R. § 876.3750 (1995), the designation given to those devices subject to the most stringent MDA controls, see Duvall v.”
Jessen v. Mentor Corp., 158 Cal. App. 4th 1480 (Cal. Ct. App. 2008). “3530 (2007)) and “solid or gel-filled silicone rubber prosthesis] that [are] implanted surgically to resemble a testicle” ( 21 C.F.R. § 876.3750 (2007); see Goldsmith v.”
Goldsmith v. Mentor Corp. (D.N.H. 1995). · cites it 2× “6 21 C.F.R. § 876.3750 (1995), the designation given to those devices subject to the most stringent MDA controls, see Duvall v.”
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