---
kind: "section"
citation: "21 C.F.R. § 886.4155"
title: "21"
number: "886.4155"
heading: "Scleral plug."
url: "https://uscodex.org/cfr/21/886.4155"
---

# §886.4155. Scleral plug.

- (a) **Identification.** A scleral plug is a prescription device intended to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. These plugs prevent intraocular fluid and pressure loss when instruments are withdrawn from the eye. Scleral plugs include a head portion remaining above the sclera, which can be gripped for insertion and removal, and a shaft that fits inside the scleral incision. Scleral plugs are removed before completing the surgery.
- (b) **Classification.** Class II (special controls). The special controls for the scleral plug are as follows:
  - (1) The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 886.9](/cfr/21/886.9.md) if the material is a surgical grade stainless steel with or without a gold, silver, or titanium coating. The special controls for the surgical grade stainless steel scleral plug (with or without a gold, silver, or titanium coating) are:
    - (i) The device must be demonstrated to be sterile during the labeled shelf life;
    - (ii) The device must be demonstrated to be biocompatible; and
    - (iii) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.
  - (2) The device is not exempt from premarket notification procedures if it is composed of a material other than surgical grade stainless steel (with or without a gold, silver, or titanium coating). The special controls for scleral plugs made of other materials are:
    - (i) The device must be demonstrated to be sterile during the labeled shelf life;
    - (ii) The device must be demonstrated to be biocompatible;
    - (iii) Characterization of the device materials must be performed;
    - (iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device;
    - (v) Performance data must demonstrate adequately low levels of the extractables or residues from manufacturing (or processing) of the device; and
    - (vi) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.

## Notes

### Amendments

[78 FR 68715, Nov. 15, 2013]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

[78 FR 68715, Nov. 15, 2013]