21 C.F.R. § 878.4025
Silicone sheeting.
Cite as 21 C.F.R. § 878.4025 (2026)
(a)
Identification.
Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
[69 FR 48148, Aug. 9, 2004]
- Cross-references to the CFR
- 878.9.